Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 7
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.
详细描述
To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.
The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
- •Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
- •The patient is willing and able to cooperate with study procedures and required follow up visits
排除标准
- •Women with known pregnancy or who are lactating
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
- •Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
TLF defined as a composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.
次要结局
- Major Adverse Cardiac Events (MACE)(12 months)
- Stent Thrombosis(12 months)
- Any Myocardial Infarction (MI)(12 months)
- Any Repeat Revascularization(12 months)
- Target Vessel Failure (TVF)(12 months)
- All Deaths(12 months)