Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 37
- 主要终点
- Efficacy Endpoint. Freedom fromTarget Lesion Failure
研究概览
简要总结
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
详细描述
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Coroflex® ISAR NEO is intended to be used for
- •Patients must be at least 18 years of age AND
- •The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND
- •Patients with Novo lesion length 2-4 mm AND
- •Informed consent signed
排除标准
- •Patients with express refusal by the patient to participate in the study.
- •Patients pregnant women and lactating women.
- •Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
- •Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
- •Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
- •Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
- •Patients with known sensitivity to contrast agents who cannot be premedicated.
- •Patients with contraindications or hypersensitivity to sirolimus
- •Patients with a life expectancy of less than 2 years
- •Patients included in other clinical trials
研究组 & 干预措施
Coronary Artery Disease (CAD)
干预措施: Coroflex® ISAR NEO coronary stent system (Device)
Coronary Artery Disease (CAD) and high risk of bleeding
干预措施: Coroflex® ISAR NEO coronary stent system (Device)
结局指标
主要结局
Efficacy Endpoint. Freedom fromTarget Lesion Failure
时间窗: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Safety Endpoint. Freedom from Target Lesion Failure
时间窗: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)
次要结局
- Freedom from Balloon rupture(During PCI)
- Freedom from Hypotube rupture(During PCI)
- Freedom from Coronary thrombosis(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from Accidental dislodgement of the stent(During percutaneous coronary intervention (PCI))
- Freedom from Complicated withdrawal(During PCI)
- Freedom from Coronary perforation(During PCI)
- Freedom from No reflow(During PCI)