CTRI/2024/02/062438尚未招募4 期
A prospective, single-arm, multi-centre study to evaluate the safety and performance of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System by clinical and imaging outcomes in patients with coronary artery disease - RESET
Meril Diagnostics Private Limited0 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
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients aged =18 years.
- •2. Patients with de novo coronary artery lesions with reference vessel diameter of =2.75 mm to =4.0 mm.
- •3. Patient has given written informed consent for participation prior to enrolment.
- •4. Patient is willing to undergo all study procedures and follow-up requirements.
排除标准
- •1. Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin,ticlopidine, prasugrel, ticagrelor and drug such as Sirolimuds or similar drugs or any analogue or derivative, poly-Llactide, poly-DL-lactide, platinum, or with any contrast media Patient in whom anti-platelet and/or anti-coagulant therapy are contraindicated
- •2. Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon
- •3. Pregnant or lactating female
- •4. Left main coronary artery disease
- •5. Aorta ostial lesion and Lesion in a bypass graft
- •6. Any PCI less than 6 months prior to the index procedure
- •7. Previous CABG in the target vessel
- •8. And other exclusions as specified in the protocol
研究者
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