coronary artery disease coronary artery stenosis
Conditions
Interventions
Alle subjects will undergo coronary angiography and PCI with study stent
implantation (BioNIR or Resolute). The stent will remain implanted during the
follow-up period, in total 5 years.
Sponsors
Medinol Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age * 18 years. 2. Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of *70%, a positive non-invasive stress test, or FFR *0.80 must be present), NSTEMI, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked. 3. Non-target vessel PCI are allowed prior to randomization depending on the time interval as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as:
Exclusion criteria
Exclusion criteria: 1. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or patients in whom enzyme levels (either CK-MB or Troponin) have not peaked. 2. PCI within the 24 hours preceding the baseline procedure. 3. Non-target lesion PCI in the target vessel within 12 months of the baseline procedure. 4. History of stent thrombosis. 5. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure 700,000 cells/mm3. 12. White blood cell (WBC) count <3,000 cells/mm3. 13. Clinically significant liver disease. 14. Active peptic ulcer or active bleeding from any site. 15. Bleeding from any site within the prior 8 weeks requiring active medical or surgical attention. 16. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath. 17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions. 18. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA. 19. Known allergy to the study stent components, whether in the BioNIR or Resolute, e.g. cobalt, nickel, chromium, molybdenum, Carbosil®, PBMA, Biolinx polymer, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds). 20. Known allergy to protocol-required concomitant medications such as aspirin, or DAPT (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated. 21.Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease). 22. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint. 23. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment). 24. Women who intend to procreate within 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure). 25. Patient has received an organ transplant or is on a waiting list for an organ transplant. 26. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the baseline procedure. 27. Patient is receiving oral or intravenous immunosuppressive therapy or has known life- limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed.;Angiographic Exclusion Crite
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) at 12 months defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5, except as noted: * Device, Lesion, and Procedure Success at time of baseline procedure * TLF at 30 days, 6 months, and 2, 3, 4 and 5 years defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR. * Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR) * Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR) * All-cause mortality * Cardiac death * Myocardial Infarction * Target Vessel Related MI * Ischemia-driven TLR * Ischemia-driven TVR * Stent Thrombosis (ARC definite and probable) Angiographic Sub-Study Secondary Endpoint to be evaluated at 13 months: * Angiographic in-stent and in-segment late loss IVUS Sub-Study Secondary Endpoint to be evaluated at 13 months: * In-stent percent neointimal hyperplasia * Stent mal-apposition | — |
Countries
Netherlands
Outcome results
None listed