Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 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 clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).
详细描述
This is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the Supraflex Cruz SES in an unselected, all-comer patient population with multivessel disease. The multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the Supraflex Cruz SES. The registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (CAD) as well as acute coronary syndrome (STEMI and NSTEMI).
All patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure.
Subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of Target Lesion Failure (TLF) at 12 months. The following subgroups are pre-defined according to their presentation at enrolment:
- Treatment in relation to clinical presentation [Acute Coronary Syndrome (ACS)]
- Treatment in relation to specific lesion subsets [Left Main, Chronic Total Occlusion]
- Patients undergoing atherectomy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 18 years of age
- •Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure
- •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
- •The patient is willing and able to co-operate 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
- •Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
研究组 & 干预措施
Patient population with multivessel disease
Supraflex Cruz Sirolimus-eluting Coronary Stent System
干预措施: Supraflex Cruz Sirolimus-eluting Coronary Stent System (Device)
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
TLF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)".
次要结局
- Target Lesion Failure (TLF)(30 days, 6 months)
- All-cause mortality(30 days, 6 months, and 12 months)
- Any myocardial infarction (MI), includes non-target vessel territory(30 days, 6 months, and 12 months)
- Any revascularization(30 days, 6 months, and 12 months)
- Definite/probable stent thrombosis(30 days, 6 months, and 12 months)
- Target Vessel Failure (TVF)(30 days, 6 months, and 12 months)