CTRI/2017/10/010239招募中4 期
A prospective, active control, open-label, multi-centre, randomized clinical trial comparing BioMime Branch - Sirolimus Eluting Coronary Side Branch Stent System vs. any Contemporary Drug-eluting stents to evaluate safety and performance in patients with de novo coronary bifurcation lesions. - BioMime Branch - Sirolimus Eluting Coronary Side Branch Stent System
Meril Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •The patient should meet all of the inclusion criteria.
- •1. The patient must be greater than or equal to 18 years of age.
- •2. Maximum one de novo bifurcation lesion per patient.
- •3. True coronary bifurcation, greater than or equal to 50 percent diameter stenosis in both the main and side branches, belonging to the Medina classes 1,1,1/1,0,1 or 0,1,1.
- •4. Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure.
- •5. Visually estimated target lesion reference vessel diameter, 2.5-4.0 milimeter in the main branch, greater than or equal to 2.5 milimeter in the side branch.
- •6. Childbearing potential female patients with negative pregnancy test result within 7 days before trial procedure.
- •7. Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure.
- •8. The patient is willing to comply with protocol specified follow-up evaluations.
- •9. Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities.
排除标准
- •Any patient who meets any of the following criteria will be excluded from the study.
- •1. Patient with known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, antiplatelet medication specified for use in the study, Everolimus and Sirolimus, PLLA, PLGA, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- •2. Life expectancy less than 1 year.
- •3. Acute myocardial infarction (less than 1 week).
- •4. Left ventricular ejection fraction less than 30 percent (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- •5. Angiographic evidence of thrombus.
- •6. Impaired runoff in the target vessel with diffuse distal disease.
- •7. Target lesion having excessive torsousity unsuitable for the stent delivery.
- •8. Patient requiring anticipated rotational atherectomy as per the Investigator’s judgement.
- •9. Known renal insufficiency (e.g., estimated glomerular filtration rate less than 60 mililitre per kilogram per meter square or serum creatinine level of greater than 2.0 miligram per decilitre, or patient on dialysis).
- •10. Pregnant or nursing patients or those who plan pregnancy in the period up to 2 years following index procedure.
- •11. Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant.
- •12. Highly calcified lesions in which full stent dilatation may not be possible.
- •13. Patient judged to have lesion that prevents complete inflation of an angioplasty balloon.
- •14. Previous PCI of the target lesion
- •15. Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease.
- •16. An elective surgery planned within 1 year after the procedure that will require discontinuing of DAPT.
- •17. Platelet count less than 100,000 cells per millimeter cube or greater than 700,000 cells per millimeter cube or a WBC less than 3,000 cells per millimeter cube.
- •18. History of bleeding diathesis or coagulopathy.
- •19. Patient has had a Cerebrovascular Accident (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
- •20. Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment.
- •21. Patient belonging to a vulnerable population (per investigator judgment, e.g., subordinate hospital staff or Sponsor staff).
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