NL-OMON47650已完成不适用
BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial - BIONICS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medinol Ltd.
- 入组人数
- 119
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection * NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.
- •b. Less than 24 hours prior to Baseline Procedure:
- •i. Not allowed (see exclusion criteria #2).
- •c. 24 hours-30 days prior to Baseline Procedure:
- •i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above.
- •ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI.
- •iii. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.
- •d. Over 30 days prior to Baseline Procedure:
- •i. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated.
- •4. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.;Angiographic inclusion criteria (visual estimate)
- •5. Target lesion(s) must be located in a native coronary artery or bypass graft conduit with visually estimated diameter of *2.5 mm to *4.25 mm.
- •6. Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), presence of thrombus, CTO, bifurcation lesions (except as noted in exclusion criteria #30), ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions, and saphenous vein graft lesions.
- •7. Overlapping stents are allowed.
排除标准
- •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 <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
- •6. Subject is intubated.
- •7. Known LVEF <30%.
- •8. Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or on or indicated for chronic oral anticoagulant treatment).
- •9. Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation (<40 mL/min for subjects participating in the angiographic follow-up sub-study).
- •10. Hemoglobin <10 g/dL.
- •11. Platelet count <100,000 cells/mm3 or >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
研究者
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