Metalless PCI Registry - A prospective, single-arm, single-centre registry to evaluate safety and performance of Bioresorbable Vascular Scaffold along with drug-eluting balloon in patients with long diffused de-novo coronary lesions.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF) [Time Frame: 1 year]
研究概览
简要总结
The currently approved MeRES 100 – is a novel 100micron thick bio-resorbable PLLA scaffold has been tested and found safe and effective among Indian CAD patients. MeRES 100 has been available for human use for PCI since January 2021 and currently its use is restrictive for few types of CAD lesions that are short segment involvement in vessels over diameter 2.75mm or more up to 4.0mm. As CAD affects many young subjects in India, this MeRES Bio-resorbable scaffold offers an effective PCI solution to many with single or multi-vessel CAD involvement and retains the option of further PCI or CABG surgery should the atherosclerosis disease progresses in these patient subjects in future unlike metal jacketed DES in the vessels that precludes graft anastomosis in such vessels implanted with DES
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged greaterthan equal to 18 years.
- •2.Patients with long diffused de-novo coronary lesions greaterthan 25 mm suitable for treatment with BRS along with drug eluting balloon.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 Sirolimus Rapamycin or similar drugs or any analogue or derivative, poly L lactide PLLA, poly DL lactide PDLLA, platinum, or with any contrast media.2.Patient in whom antiplatelet and or anti coagulant therapy are contraindicated.3.Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon.4.Transplant patient.
- •5.Patients with low ejection fraction Lessthan30percentage 6.Renal insufficiency where creatinine levels are more than 1.3 mg per dl 7.Patients with vascular aneurysms 8.Lesion located in left main coronary artery 9.Aorto ostial location within 3 mm 10.Patients with Chronic Total Occlusions 11.Patients with bifurcation or trifurcation lesion disease or multivessel complex lesions 12.Patients with severely calcified vessels and angulations 13.Subject is high risk of bleeding for any reason.14.Pregnant or lactating female.
- •15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study.
结局指标
主要结局
Target Lesion Failure (TLF) [Time Frame: 1 year]
时间窗: one month ,six month , one year, Two Years ,Three Years ,Four Years ,Five Years
Defined as the composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a non-target vessel), or ischemia-driven target lesion revascularization (ID-TLR)[1].
时间窗: one month ,six month , one year, Two Years ,Three Years ,Four Years ,Five Years
次要结局
- .Stroke: [Time Frame: Time Frame: 1 month, 6 months, 1 year, 2years, 3 years, 4 years, 5 years][5](8.Thrombosis [Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years])
研究者
Dr Sadanand Reddy
ESIC Hospital ,sanath Nagar, Hyderabad