A ProSpective, multicentre, registry to evalUate the Clinical outCome of Encruso RAL-EverolimusEluting Coronary Stent System in real world percutaneOus coronary revasculaRization in Indian population- SUCCESSOR

Nano Therapeutics Private Limited18 个研究点分布在 1 个国家目标入组 500 人开始时间: 2022年3月21日最近更新: 2024年9月5日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 500
试验地点: 18
主要终点: and

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

It is a prospective, multi-center, non-randomized, registry study with clinical follow up to be conducted at 30 days, 180 days, year 1 and year 2 post index procedure. 500 patients to receive treatment with the Encruso RAL-Everolimus Eluting Coronary Stent.The primary objective of the study is to evaluate the safety and efficacy of the Encruso RAL-Everolimus eluting coronary stent system implanted during routine clinical practice in India at 1 year follow up. 50 patients out of 500 will be included in the OCT sub study. The primary objective of the study is to evaluate the malapposition, degree of strut coverage and vessel wall response after implantation of Encruso RAL-Everolimus Eluting Coronary Stent by Optical Coherence Tomography at 6 months angiographic follow up. The sub study is designed to run seamlessly with the main study but sites can opt out if they choose not to participate.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 98.00 Year(s)（—）
性别: All

入选标准

•1.Male or female patient who is 18 years and above 2.Patients undergoing percutaneous coronary intervention with Encruso RAL-Everolimus Eluting Coronary Stent System 3.Patient or legal guardian understands the study requirements and provides written informed consent 4.Patient who is on dual antiplatelet therapy for at least 6 months post procedure.

排除标准

•1.Patient has known hypersensitivity or allergies to Aspirin, Heparin,Clopidogrel, Ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, or contrast media 2.Patient with life expectancy less than 2 years 3.Pregnant and lactating females or planning to become pregnant while in the study 4.Patient currently participating in another investigational drug or device clinical trial.