protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02052778 | 15 | CONFIDENTIALITY AND DATA PROTECTION | 15. CONFIDENTIALITY AND DATA PROTECTION All information provided to the investigator by the sponsor or sponsor's representatives, information produced during the clinical trial including, but not limited to, the protocol, eCRF, IB, and the results obtained during the course of the trial are confidential. The members of... | [] |
NCT02052778 | 16 | SIGNATURES OF SPONSOR AND INVESTIGATOR | 16. SIGNATURES OF SPONSOR AND INVESTIGATOR PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS
a. Declaration of Sponsor This study protocol was subject to critical review and has been approved by the appropriate protocol review committee of the sponsor. The information it ... | [
"a. Declaration of Sponsor",
"b. Declaration of Investigator"
] |
NCT02052778 | 17 | REFERENCES | 17. REFERENCES - 1. Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100:57-70. - 2. Eswarakumar VP, Lax I, Schlessinger J. Cellular signaling by fibroblast growth factor receptors. Cytokine Growth Factor Rev. 2005 Apr;16(2):139-49. - 3. Fukumoto S. Actions and mode of actions of FGF19 subfamily member... | [
"APPENDIX A. LIST OF FGFR MUTATIONS",
"Criteria for selecting mutations",
"APPENDIX B. FGFR3 MUTATIONS",
"APPENDIX C. ECOG PERFORMANCE STATUS",
"APPENDIX D. NEW YORK HEART ASSOCIATION (NYHA) CLASSIFICATION",
"The Stages of Heart Failure NYHA Classification",
"APPENDIX E. DIETARY GUIDELINES FOR TREATMENT... |
NCT02167074 | A | Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device with a 20G EUS ProCore Fine Needle Biopsy (FNB) Device | A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device with a 20G EUS ProCore Fine Needle Biopsy (FNB) Device ASPRO trial (ASPiration versus PROcore) ProCore study group
PROTOCOL TITLE | ProtocolID | ASPRO trial | |--------------------------------------|--------------------------------... | [
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NCT02213380 | 7 | Anesthesia: | 7. Anesthesia: Because of the particularity of senile anesthesia, experienced anesthesiologists are required to carry out anesthesia. They need to master nerve block, intraspinal anesthesia, and general anesthesia and be competent for anesthesia in elderly hip fracture surgery. 1) Preoperative, intraoperative, and post... | [
"Description:"
] |
NCT02228590 | A | Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients with Parkinson's Disease PROTOCOL CTH-105 IND N/A | A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients with Parkinson's Disease PROTOCOL CTH-105 IND N/A NUMBER: PROTOCOL DATE: 10 September 2014 SPONSORED BY: Cynapsus Therapeutics Inc. Information contained within is confidential and may not be used, divulged, published, or otherwi... | [
"1. SIGNATURES OF AGREEMENT FOR PROTOCOL",
"2. EMERGENCY CONTACT INFORMATION",
"3. INVESTIGATOR APPROVAL STATEMENT",
"9. OBJECTIVES",
"9.1 Clinical Objective",
"9.2 Primary Variables",
"9.3 Secondary Variables",
"16.5 Subject Injury",
"ADVERSE REACTIONS Clinical Trial Experience Adverse Events Incid... |
NCT02315066 | A | PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS | A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS Compounds: PF-04518600 and PF-05082566 Compound Name: Not Applicable (N/A) for PF-04518600 Utomilumab for PF-05082566 United States (US) Inve... | [
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"• The secondary endpoints of time to event endpoints have been re-categorized as \"Anti-tumor activity assessments\" to better reflect the endpoints as they are not all time to event endpoints in nature and this is more in alignment with the Food and Drug Administration (FDA) gui... |
NCT02415842 | 1 | INTRODUCTION | 1 INTRODUCTION | [] |
NCT02415842 | 14 | Background | 14. Background Influenza i an acute, highly contagious,respiatory disease caused by influenza viruses, 'mainly spread through respiratory droplets. The ilness is accompanied by fever and variable degrees of other systemic symptoms, rnging from mild fatigue fo respiratory foilure and death. nfluenza occurs in aunual pid... | [
"124, Rationale for the study"
] |
NCT02415842 | 24 | Co-Primary objectives | 24. Co-Primary objectives With respect 10 samples from the HA Group L-related stuies (.., with HINL, HSN1 and HIN?2 pandemic, and 11V'4 seasonal,influenza vaccines) - 1. To describe the anti-H1 stalk ELISA antibody levels: - « In adult subject samples of the CC-Pan HSNI-001, the Q-Pan HINI-019 'and the Q-Pan HON2-001 s... | [
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"a, STUDY COHORT 44, Number of samples",
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NCT02415842 | 54 | Regulatory and ethical considerations, including the informed consent process | 54. Regulatory and ethical considerations, including the informed consent process "The study wil be conducted in accordance with all applicable regulatory requirements. "The study will be conducted in accordance with the ICH Guideline for Good Clinical Practice (GCP),all applicable subject privacy requiremnents aud the... | [
"542, Blological samples evaluation 5421, Immunological read-outs",
"6. STUDY VACCINES AND ADMINISTRATION"
] |
NCT02415842 | 64 | Description of study vaccines | 64. Description of study vaccines See the table below for the vaccine strains administered in the primiary prospective studies. Table7 Description of study vaccines (Amended 01 Septomber 2016) Studyno. Vaccine stain Sardan The dosage and administration (intramuscular in all cases) of study vaccines in the previously co... | [
"7. HEALTH ECONOMICS",
"8. SAFETY",
"10. STATISTICAL METHODS",
"104, Primary endpoints"
] |
NCT02415842 | 102 | Secondary endpoints | 102. Secondary endpoints With respect 1o samples from the HA Group related studies (i.c., with HINY, HSNI, and HIN?2 pandemic, and V4 seasonalinfluenza vaccines): - Levels of anti-H1 stalk antibody by ELISA for allthe subjects in the adult CC-Pan HSN1-001, the Q-Pan HINI-019and the Q-Pan HIN2-001 study cohorts 'The fol... | [] |
NCT02415842 | 103 | Tertiary endpoints. | 103 Tertiary endpoints. With respect 10 samples from the HA Group I-related studles (i.c., with HINY, HSNI, and HIN?2 pandemic, and 11V seasonal,influenza vaccines): orsepa0te ® - L Levels of anti-N1 NA antibody by ELISA for subjects in the HINT study cohort. The following aggregate variables wil be calculated witlh 95... | [
"104, Determination of sample size",
"10.7.1. Within groups assessment",
"Between groups assessment",
"10.7.24. For adult HSN1, HON2, and H1NA study cohorts)"
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NCT02415842 | 107.22 | For HTN9 study only | 107.22. For HTN9 study only - « For N9 study andfor anti-H3 statk ELISA results, if available: - The difference in percentage of subject with at least 4-fold increase at all applicable timepoints (D21, D2, DI82, and D38S) for which data are available comparedto0 Day 0 (ie. adjuvanted group minus non-adjuvanted group, a... | [
"108, Analysis of safety"
] |
NCT02415842 | 109 | Conduct of analyses | 109. Conduct of analyses "The planned analysis s deseriptive and wil be performed for each treatment group in the individual study cohorts. Any deviation(s) or change(s) from the original stafstical plan outlined in this protocol will be described and justified in the final study report.
10, 'Sequence of analyse: Aual... | [
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"112, Study Monitoring by GSK Biologicals.",
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"APPENDIXA LABORATORY ASSAYS",
"1. Immunogenicity Assays: ELISA protocol:",
"Materiais:",
"TPBS",
"Blocking solution",
"Preparation:",
"... |
NCT02415842 | 122 | Rationale for the study design | 122 Rationale for the study design "This retrospective sty is designed 10 asess immunogenicty (i ferms of the humoral mmune response {0 the H1 hemagglutinin stalk domain and other influenzaA virus proten epitopes) of HSN1, HIN 09, nd HON2 adjuvanted or mnadjuvanted pandemic influenza vaccine (standard adult dose) using... | [
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"44, Numberof samples",
"104. Primary endpoints",
"103, Tertiary endpoints",
"108: Within groups assessment"
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NCT02415842 | 10101 | Sequence of analyses | 10101 Sequence of analyses Analysis will be performed on final and clean data; analysis of dta from the adit HSN1 study will be performied frst and then for the three other study cohorts (i.c., pediatric HSNI HINT and HIN2), pending any necessary change in the samiple testing plan. Results will be presented in a final ... | [
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NCT02415842 | 10101 | Sequence of analyses | 10101 Sequence of analyses Analyses wil be performed in sequence based on availabiliy of the different results. S hange-n sample-tosing-plas - Results will be presented in a fnal study repart. orsepaote 7
1002 Statistical considerations for int im analyses 1 Administrative Matters 'Not applicable since o intritn analy... | [
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"112 Study Monitoring by GSK Biologicals",
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"registers and publication policy",
"APPENDIXA LABORATORY ASSAYS",
"Exploratory protocol endpoints (to-be-placedtin-the-main-protocot-sr-well) opeive Exdpoint"... |
NCT02561455 | A | Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial | A Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
Protocol for Phase 1/2 Study of ASP2215
ISN/Protocol 2215-CL-0109
Version 2.1
Incorporating Non-Substantial Amendment 1 [See Attachment 1] 19 July 2018 NCT02561455 IND 117,548
Sponsor:
Astellas Pharma G... | [
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NCT02561455 | A | Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial | A Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial ISN/Protocol 2215-CL-0109
Version 2.1 Incorporating Non-Substantial Amendment 1
19 Jul 2018 I have read all pages of this clinical study protocol for which Astellas is the Sponsor. I agree to conduct the st... | [
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"III. LIST OF ABBREVIATIONS AND DEFINITION OF KEY TERMS",
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NCT02603835 | 1 | INTRODUCTION | 1 INTRODUCTION The IC-HOT clinical study presented in this Investigational Plan is designed as a confirmatory study enrolling 100 patients with qualifying anterior acute myocardial infarction (AMI) treated with successful percutaneous coronary intervention (PCI) with stenting within 6 hours of symptom onset. This study... | [] |
NCT02603835 | 2 | BACKROUND INFORMATION | 2 BACKROUND INFORMATION TherOx has conducted four FDA-approved IDE clinical studies for treatment of AMI patients. The first study was a pilot effort conducted on twenty-nine patients; study results included promising trend data towards improved left ventricular ejection fraction and wall motion score in SSO2 Therapy t... | [] |
NCT02603835 | 2.1 | Description of Device | 2.1 Description of Device SuperSaturated Oxygen Therapy ("SSO2 Therapy") is an adjunctive cardiac catheterization laboratory initiated procedure with superoxygenated blood delivered via a qualified delivery catheter to the left main coronary artery (LMCA) in a patient with acute myocardial infarction (AMI) after succes... | [] |
NCT02603835 | 2.1.1 | DownStream System | 2.1.1 DownStream System The system is the electromechanical device (console) that controls the cartridge and monitors performance and safety during administration of SSO2 Therapy. The system has safety features that continuously monitor system parameters such as the blood flow rate and pressure, and detect potentially ... | [] |
NCT02603835 | 2.1.2 | DownStream Cartridge | 2.1.2 DownStream Cartridge The cartridge is a single-use disposable device that is loaded into the system by a trained healthcare professional. The cartridge has a three-chambered body that creates SSO2 solution from inputs of hospital-supplied oxygen and physiologic saline and mixes the SSO2 solution with arterial blo... | [] |
NCT02603835 | 2.1.3 | SSO2 Delivery Catheter | 2.1.3 SSO2 Delivery Catheter The SSO2 delivery catheter is a 5F (O.D.) over-the-wire catheter that is equipped with a standard luer fitting at the proximal end for attachment to the return line of the cartridge. The SSO2 delivery catheter has a total length of 100 cm and is placed over a guidewire to reach the coronary... | [] |
NCT02603835 | 2.1.4 | Patient Connections | 2.1.4 Patient Connections The DownStream Cartridge draw tubing connects to a femoral arterial sheath that may be used for angioplasty and stenting procedures. Sheath placement may be coaxial (using one femoral arterial access site) or contralateral (using both the right and left femoral arteries for access sites), at t... | [] |
NCT02603835 | 3 | STUDY OBJECTIVE | 3 STUDY OBJECTIVE To collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in the treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms. | [] |
NCT02603835 | 4 | STUDY DESIGN | 4 STUDY DESIGN This is a non-randomized, single-arm study. Subjects who present with anterior STEMI requiring stent placement in the proximal and/or mid LAD who meet all inclusion and exclusion criteria and provide informed consent will be treated with primary PCI with stenting, and if successful and uncomplicated then... | [] |
NCT02603835 | 4.1 | Patient Enrollment | 4.1 Patient Enrollment 100 qualifying patients with anterior acute myocardial infarction will be enrolled into this study and treated with SSO2 Therapy only after successful and uncomplicated revascularization of the LAD infarct artery. | [] |
NCT02603835 | 4.2 | Patient Follow-Up | 4.2 Patient Follow-Up Subjects will be followed clinically at baseline, procedural, in hospital, at 30-days (±7 days; i.e., between 23 and 37 days), at 6-months (±30 days) and at 12-months (±30 days) following the index procedure. The clinical investigator or designee will conduct the 30-day follow-up assessment as an ... | [] |
NCT02603835 | 4.3 | Cardiac Magnetic Resonance Imaging (MRI) | 4.3 Cardiac Magnetic Resonance Imaging (MRI) Patients will be evaluated with two cardiac MRI scans. The first scan will be conducted between day 3 and day 5 post-procedure (day 4 ± 1). The second scan will be conducted in conjunction with the mandatory 30-day clinical follow-up visit, on day 30 (±7) postprocedure (betw... | [] |
NCT02603835 | 4.4 | Early Study Termination | 4.4 Early Study Termination No statistical rule for early termination is defined. However, TherOx, Inc. may discontinue the study at any stage with written notice to the investigators. Possible reasons for early termination may include identification of safety risks that pose an unreasonable risk to the patient. The in... | [] |
NCT02603835 | 4.5 | Measures Taken To Avoid / Minimize Bias | 4.5 Measures Taken To Avoid / Minimize Bias In order to minimize bias in assessing both effectiveness and safety data, the independent cardiac MRI Core Laboratory will evaluate patient scans independent of clinical outcome data, and an independent Clinical Events Committee (CEC) will be utilized for adverse event codin... | [] |
NCT02603835 | 5 | SSO2 THERAPY PROCEDURAL AND SAFETY DATA | 5 SSO2 THERAPY PROCEDURAL AND SAFETY DATA | [] |
NCT02603835 | 5.1 | SSO2 Therapy Procedural Data | 5.1 SSO2 Therapy Procedural Data Procedural information will be collected and reported for every patient treated with SSO2 Therapy in this trial. The data collected and reported will include: - SSO2 Therapy device and infusion specifics - Confirmation of stable delivery catheter position - Intra-procedural hemodynamics... | [] |
NCT02603835 | 5.2 | Safety Data | 5.2 Safety Data All major adverse events will be evaluated and reviewed by an independent Clinical Events Committee ("CEC"). The following safety and procedural information will be reported and summarized: - AEs and SAEs - Adverse event relationships - Intraprocedural complications - Clinical, technical and procedural ... | [] |
NCT02603835 | 5.3 | Number of Sites | 5.3 Number of Sites Up to fifteen (15) centers located in the U.S. | [] |
NCT02603835 | 5.4 | Sample Size | 5.4 Sample Size One hundred (100) patients, non-randomized. All patients will receive a 60-minute SSO2 Therapy infusion. | [] |
NCT02603835 | 6 | PATIENT SELECTION AND WITHDRAWAL | 6 PATIENT SELECTION AND WITHDRAWAL | [] |
NCT02603835 | 6.1 | Patient Population | 6.1 Patient Population Patients must meet all of the study criteria outlined below in Section 6.4.1 and 6.4.2 (reference Inclusion/Exclusion Criteria Case Report Form (CRF), Appendix A). No exclusion criteria outlined in Section 6.4.2 may apply in order to be enrolled. | [] |
NCT02603835 | 6.2 | Patient Screening | 6.2 Patient Screening All patients admitted to the emergency room or cardiac catheterization laboratory with symptoms <6 hours after symptom onset and ECG findings suggestive of acute anterior AMI (ST-segment elevation of ≥1 mm in 2 or more contiguous leads in V1-V4, or new left bundle-branch block), and who are consid... | [] |
NCT02603835 | 6.3 | Informed Consent | 6.3 Informed Consent A member of the research team will approach the patient (or legal representative) to obtain written Informed Consent. The Informed Consent will be carefully explained to the patient. The patient (or legal representative) must sign the consent form approved by the Sponsor, FDA, and the study site's ... | [] |
NCT02603835 | 6.4 | Eligibility Criteria | 6.4 Eligibility Criteria | [] |
NCT02603835 | 6.4.1 | Inclusion Criteria | 6.4.1 Inclusion Criteria Candidates for this study must meet ALL of the following criteria:
General Inclusion Criteria
Pre-PCI: - 1. The subject must be ≥18 and ≤80 years of age. - 2. AMI must be anterior (ST-segment elevation >1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block). -... | [
"General Inclusion Criteria",
"Pre-PCI:"
] |
NCT02603835 | 6.4.2 | Exclusion Criteria | 6.4.2 Exclusion Criteria Subjects will be excluded if ANY of the following conditions apply:
General Exclusion Criteria
Pre-PCI: - 1. Prior CABG surgery. - 2. Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction 15 seconds; and - j. Known hypersensitivity or contraindication to ga... | [
"General Exclusion Criteria",
"Pre-PCI:"
] |
NCT02603835 | 6.5 | Patient Discontinuation | 6.5 Patient Discontinuation Once enrolled, each patient should remain in the study until the required follow-up period is complete. However, the patient has the right to withdraw from the study at any time. The following events will result in terminating the patient's follow-up: - Patient death - Patient voluntary with... | [] |
NCT02603835 | 6.5.1 | Lost To Follow-Up | 6.5.1 Lost To Follow-Up Patients who do not complete the scheduled 30-day follow-up clinical visit or who cannot be contacted for their 6 and 12-month telephone surveys and have not officially withdrawn from the study are considered lost to follow-up; this term does not apply to missed visits. Site personnel should mak... | [] |
NCT02603835 | 7 | STUDY PROCEDURES | 7 STUDY PROCEDURES | [] |
NCT02603835 | 7.1 | Patient Evaluation Procedures | 7.1 Patient Evaluation Procedures For those patients who agree to participate in the study by signing the approved Informed Consent, the following baseline examinations and tests will be performed: - Medical History and physical examination - 12 Lead ECG - Administration of protocol required procedure medications - Car... | [] |
NCT02603835 | 7.2 | Procedure Medications | 7.2 Procedure Medications All enrolled patients receive the following protocol required medications: Patients must receive one of the following oral ADP antagonist regimens: - Clopidogrel 600 mg in the ER, followed by 75 mg to 150 mg per day. - Prasugrel 60 mg in the ER followed by 5 mg to 10 mg per day. - Ticagrelor 1... | [
"Patients must also receive:"
] |
NCT02603835 | 7.3 | Cardiac Catheterization Laboratory (CCL) Procedure | 7.3 Cardiac Catheterization Laboratory (CCL) Procedure | [] |
NCT02603835 | 7.3.1 | Patient Anticoagulation | 7.3.1 Patient Anticoagulation Patient anticoagulation throughout the SSO2 Therapy procedure is aligned with current practice in STEMI patients treated with primary PCI as outlined below. Bivalirudin is recommended for this study, but patient anticoagulation must consist of one of the following regimens: - 1) Bivalirudi... | [] |
NCT02603835 | 7.3.2 | Coronary Angiography | 7.3.2 Coronary Angiography It is recommended that the prospective patient be transferred to the catheterization laboratory as quickly as possible. Once in the catheterization laboratory, the patient should be prepared for the interventional procedure according to standard hospital procedures. Left ventriculography is r... | [] |
NCT02603835 | 7.3.3 | PCI / Stenting Procedure | 7.3.3 PCI / Stenting Procedure Following a successful diagnostic catheterization and identification of the target lesion(s) in the proximal and/or mid LAD as suitable for PCI with stenting, if heparin plus a GP IIb/IIIa inhibitor was used as the procedural anticoagulant, additional heparin boluses may need to be admini... | [] |
NCT02603835 | 7.4 | SSO2 Therapy | 7.4 SSO2 Therapy | [] |
NCT02603835 | 7.4.1 | Arterial Sheath Selection | 7.4.1 Arterial Sheath Selection The coaxial (single arterial stick) approach is strongly recommended for SSO2 Therapy as prior studies have shown that single femoral artery access, even with a larger sheath, results in less bleeding and fewer vascular complications than bilateral femoral access. When only one arterial ... | [] |
NCT02603835 | 7.4.2 | SSO2 Therapy Infusion | 7.4.2 SSO2 Therapy Infusion Note: Refer to the DownStream System Operators Manual (Appendix C) for proper setup and operation of the DownStream System. - 1. For coaxial (one arterial access site) setup with the SSO2 delivery catheter: introducer sheath with sidearm must be in place. - 2. For dual access site setup, the... | [] |
NCT02603835 | 7.4.2.1 | Device Performance | 7.4.2.1 Device Performance DownStream System and DownStream Cartridge device usage information, including date and time of SSO2 Therapy infusion, the number of DownStream Cartridges used, DownStream Cartridge tracking information, and total SSO2 Therapy infusion time, is recorded on the SSO2 Therapy Procedure CRF. Syst... | [] |
NCT02603835 | 7.5 | Other Procedural Considerations | 7.5 Other Procedural Considerations If an IABP, Impella, or other hemodynamic support device is indicated at any point after initiation of SSO2 Therapy, prior to the completion of the 60-minute SSO2 infusion, the SSO2 procedure must be discontinued. These devices may not be operated simultaneously in this protocol. | [] |
NCT02603835 | 7.6 | Post Cardiac Catheterization Laboratory (CCL) | 7.6 Post Cardiac Catheterization Laboratory (CCL) | [] |
NCT02603835 | 7.6.1 | In-Hospital Procedures | 7.6.1 In-Hospital Procedures Following treatment, patients will be sent to the CCU, Step-Down Unit, or Coronary Care Floor at the discretion of the Investigator. | [] |
NCT02603835 | 7.6.2 | Post-procedure ECG | 7.6.2 Post-procedure ECG A 12-lead post-procedure ECG must be obtained at 60 minutes (±30 minutes) after the last angiogram, which is taken after the final SSO2 discontinuation. | [] |
NCT02603835 | 7.6.3 | Cardiac Enzymes, Clinical Chemistry, and Hematology | 7.6.3 Cardiac Enzymes, Clinical Chemistry, and Hematology Cardiac enzymes (CK, CK-MB, and Troponin) are drawn at baseline, and at 12 and 24 hours (±2 hours) post-PCI. Clinical chemistry and hematology are obtained at baseline and at 24 hours (±2 hours) post-PCI. | [] |
NCT02603835 | 7.6.4 | Medications | 7.6.4 Medications All medications administered to study subjects must be recorded. | [] |
NCT02603835 | 7.6.5 | Cardiac MRI Scan | 7.6.5 Cardiac MRI Scan A Cardiac Magnetic Resonance Imaging scan must be performed on day 4 (±1) postprocedure (see Appendix E for detailed instructions). If the patient is unable to undergo cardiac MRI during this time window for any reason, a protocol deviation must be noted along with the reason for the inability to... | [] |
NCT02603835 | 7.6.6 | Arterial Sheath Removal and Ambulation | 7.6.6 Arterial Sheath Removal and Ambulation Arterial sheath removal and ambulation are to be conducted per standard hospital care. | [] |
NCT02603835 | 7.7 | Hospital Discharge | 7.7 Hospital Discharge Timing of hospital discharge is at the discretion of the investigator for each individual patient. An appointment for the 30-day follow-up visit should be made for a time agreeable to the patient prior to discharge. This evaluation must be performed at 30 (±7; range 23-37 days) days after index P... | [] |
NCT02603835 | 7.7.1 | Post Discharge Medications | 7.7.1 Post Discharge Medications Post discharge medications must be recorded on the Medications CRF. | [] |
NCT02603835 | 7.8 | 30-Day Clinical Visit Follow-up | 7.8 30-Day Clinical Visit Follow-up A clinical follow-up visit is required at 30 days (±7 days; range 23-37 days) post-procedure and must be completed no later than day 37 post-procedure. If the patient is hospitalized longer than 37 days the follow-up should be completed at discharge. Refer to Table 1 for details on t... | [] |
NCT02603835 | 7.9 | 6-Month and 12-Month Telephone Follow-up | 7.9 6-Month and 12-Month Telephone Follow-up A telephone follow-up call is required at 6 months (±30 days) and 12 months (±30 days) post-procedure. Refer to Table 1 for details on the assessments to be performed and the information to be collected. | [] |
NCT02603835 | 7.10 | Medical Economics Data Collection | 7.10 Medical Economics Data Collection In conjunction with this clinical trial, an economic study of hospital charges for all patients enrolled in the study will be conducted. The economic study is based on the information contained in UB-04 claim forms that are generated by the hospital billing department after patien... | [] |
NCT02603835 | 8 | RISKS AND ADVERSE EVENTS | 8 RISKS AND ADVERSE EVENTS | [] |
NCT02603835 | 8.1 | Risk Analysis | 8.1 Risk Analysis The risk management approach used by TherOx is based upon ISO 14971. The risk analysis for SSO2 Therapy was developed by a multidisciplinary team within TherOx to assess the potential hazards and causes of hazards that need to be considered in product design, testing, training, and labeling. The risk ... | [
"Risk Mitigation",
"Safety Response",
"Mitigation of Air Emboli",
"Mitigation of Blood Loss/Hemorrhage",
"Risk Analysis Summary"
] |
NCT02603835 | 8.2 | Clinical Assessments | 8.2 Clinical Assessments | [] |
NCT02603835 | 8.2.1 | Clinical Follow-Up | 8.2.1 Clinical Follow-Up Clinical follow-up with a cardiac MRI scan and an office visit will occur at 30 days (±7 days; range 23-37 days) or date of discharge, whichever is later. Additional telephone follow-up will occur at 6 months (±30 days) and 12 months (±30 days). If available, the following data should be collec... | [] |
NCT02603835 | 8.2.2 | Additional Event Driven Visits | 8.2.2 Additional Event Driven Visits Additional event driven visits may occur clinically as warranted. If available, the following data should be collected at these visits: - Clinical event descriptions. Also, AE related data including laboratory test results, ECG, details and subsequent coronary angiography results. -... | [] |
NCT02603835 | 8.3 | Adverse Events | 8.3 Adverse Events An adverse event is defined as follows for this study: Adverse Event: Any undesirable clinical occurrence in a study patient, whether or not it is related to the investigational intervention, is considered an adverse event. Any condition that was recorded as pre-existing is not an AE unless there is ... | [] |
NCT02603835 | 8.4 | Unanticipated Adverse Events | 8.4 Unanticipated Adverse Events All unanticipated adverse events MUST be reported to the study Contract Research Organization (CRO) within 24 hours of knowledge of the event. If an observed adverse event is not associated with any of the categories on the list found in Section 8.1 Risk Analysis Summary, the event may ... | [] |
NCT02603835 | 8.5 | Serious Adverse Events (SAEs) | 8.5 Serious Adverse Events (SAEs) Serious Adverse Events must be reported to the CRO within 24 hours of occurrence of the event. A serious adverse event is defined as follows for this study: Serious Adverse Event: An event that is fatal or leads to a serious deterioration in health that: - 1. Results in death - 2. Is l... | [] |
NCT02603835 | 8.6 | Clinical Events Committee (CEC) | 8.6 Clinical Events Committee (CEC) During the course of the study, an independent Clinical Events Committee (CEC) will be responsible for the adjudication of clinical events. The CEC shall consist of three members with the appropriate medical background in cardiology, including at least one interventional cardiologist... | [
"• Disease specific:",
"• Procedure related:",
"• Device specific:"
] |
NCT02603835 | 8.7 | Data Safety Monitoring Board (DSMB) | 8.7 Data Safety Monitoring Board (DSMB) The DSMB is the primary data and safety advisory board for this study. The DSMB reviews study data, monitors for excessive occurrence of adverse events, and makes recommendations to the study Sponsor regarding safety issues and risks to research participants as well as the contin... | [
"DSMB Responsibilities"
] |
NCT02603835 | 9 | REPORTING OF TRIAL DATA | 9 REPORTING OF TRIAL DATA | [] |
NCT02603835 | 9.1 | Overview | 9.1 Overview The intent of this study is to collect confirmatory safety and effectiveness data on the intracoronary perfusion of hyperoxemic blood into the left main coronary artery in patients with anterior acute myocardial infarction with successful PCI/stenting completed within 6 hours of symptom onset. 100 patients... | [] |
NCT02603835 | 9.2 | Endpoints and Statistical Analysis Plan | 9.2 Endpoints and Statistical Analysis Plan
Criteria for Study Success
Safety The primary endpoint of the IC-HOT trial to achieve study success is the 30-day rate of Net Adverse Clinical Events (NACE), compared against an objective performance goal (OPG) based from the rate of an appropriate historical control popula... | [
"Criteria for Study Success",
"Safety",
"• Stent thrombosis (ARC definite or probable)",
"Safety Endpoint: Objective Performance Goal",
"Additional Study Endpoints",
"Effectiveness",
"Study Population for Analysis"
] |
NCT02603835 | 9.3 | Medical Economics Data Analysis | 9.3 Medical Economics Data Analysis UB-04 claim forms will be requested from the hospital billing department at least 30 days after patient discharge. At the study's conclusion, UB-04 data will be reported in the aggregate form; that is, no individual patient's results will be disclosed when reporting the economic stud... | [] |
NCT02603835 | 10 | STUDY ADMINISTRATION | 10 STUDY ADMINISTRATION | [] |
NCT02603835 | 10.1 | Roles of Sponsor and CRO | 10.1 Roles of Sponsor and CRO As the study sponsor, TherOx, Inc. has the overall responsibility for the conduct of the study, including assurance that the study meets the regulatory requirements of the Food and Drug Administration, Good Clinical Practice Guidelines, and TherOx standard operating procedures. In this stu... | [] |
NCT02603835 | 10.2 | Investigator Responsibilities | 10.2 Investigator Responsibilities The investigator is responsible for ensuring the clinical study is conducted in accordance with the signed Investigator Agreement. Prior to study initiation, the investigator will forward the following essential documentation to TherOx, Inc. or their designee: - 1. A signed and dated ... | [] |
NCT02603835 | 10.3 | Direct Access to Source Data / Documents | 10.3 Direct Access to Source Data / Documents The investigator, institution or designee will permit direct access to source data/documents in order for study-related monitoring, audits, IRB review, and regulatory inspections to be performed. Consenting patients are agreeing to allow TherOx, Inc. or designee access and ... | [] |
NCT02603835 | 10.4 | Institutional Review Board (IRB) | 10.4 Institutional Review Board (IRB) The primary investigator at each site must submit the study protocol to the IRB and obtain the Committee's written approval before participating in this study. The investigator is also responsible for fulfilling any conditions or approval imposed by the IRB, such as regular reporti... | [] |
NCT02603835 | 10.5 | Consent Material | 10.5 Consent Material Part of the IRB approval must include approval of Informed Consent documents specific to the study. The investigator or other qualified personnel must administer this approved Informed Consent document to each prospective study patient, and obtain the patients signature on the document, prior to e... | [] |
NCT02603835 | 10.6 | Sponsor Responsibilities | 10.6 Sponsor Responsibilities No study site may receive shipment of all of the DownStream System components until TherOx or their designee receives the following documents: - Signed Protocol Acceptance page - Written IRB approval for conduct of the study - Signed Investigators Agreement(s) - Investigators', Co-Investig... | [] |
NCT02603835 | 10.6.1 | Study Specific Duties | 10.6.1 Study Specific Duties TherOx is the manufacturer of the DownStream System and the Sponsor of this study. TherOx has the overall responsibility for the study and will: - Select qualified Principal Investigators, clinical investigators and study sites, as well as consultants (e.g., CRO), who will participate in th... | [] |
NCT02603835 | 10.7 | Regulatory Responsibilities | 10.7 Regulatory Responsibilities | [] |
NCT02603835 | 10.7.1 | Maintaining Records | 10.7.1 Maintaining Records TherOx and/or its designee will maintain correspondence, data, adverse device events, and other records related to the clinical trial. TherOx will maintain records related to the shipment of devices and complaints. TherOx and/or its designee will maintain communication/correspondence files fo... | [] |
NCT02603835 | 10.7.2 | Submitting Reports | 10.7.2 Submitting Reports TherOx will submit required FDA reports for this investigational study. | [] |
NCT02603835 | 10.7.3 | Device Accountability | 10.7.3 Device Accountability TherOx is responsible for ensuring that the investigational site maintains accurate, up to date inventory logs for all study devices supplied by TherOx, Inc. This includes the following: subject number, date study device used, quantity and date received, quantity used, quantity returned, an... | [] |
NCT02603835 | 10.7.4 | Site Initiation | 10.7.4 Site Initiation A pre-investigational meeting will be conducted with each potential study site in order to orient the prospective investigator and staff to the investigational devices, protocol, applicable regulations and requirements, and expectations of the study, including the numbers and time frame for patie... | [] |
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