Prospective evaluation of thin-strut biodegradable polymer-coated Supraflex sirolimus-eluting stents in an all-comers patient population (S-FLEX UK-II)

Sahajanand Medical Technologies Pvt. Ltd (SMT)0 个研究点目标入组 1,904 人开始时间: 2020年7月1日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Aged 18 years or older
•2. Symptomatic coronary disease
•3. Clinical indication for PCI and stenting of at least one coronary lesion visually confirmed on coronary angiography
•4. Only Supraflex Cruz stent(s) is/are to be implanted into the coronary vasculature during the index procedure
•5. Give informed consent to participate in this registry and sign the informed consent form approved by the institutional review board of each registry site before the index PCI
•6. Agree to undergo all clinical follow-up procedures specified in the study protocol (S-FLEX UK-II) for this registry

•1. Cardiogenic shock.
•2. Pregnant or possibly pregnant
•3. Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
•4. Scheduled to undergo elective surgery within 12 months post-index PCI
•5. Currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this registry
•6. Mental incapacity, unwillingness or language barrier precluding understanding of the registry procedure or cooperation with registry site personnel

发起方

Sahajanand Medical Technologies Pvt. Ltd (SMT)