NCT04025788终止不适用
BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries With Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Target Lesion Failure at 12 months
研究概览
简要总结
BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland. After percutaneous coronary intervention (PCI) with the Magmaris scaffold and signature of the informed consent form, all subjects will be followed through hospital discharge and will undergo follow up evaluations at 6, 12 and 24 months post procedure. The follow up evaluations, part of the standard care can be either performed on site (12 months) or by phone (6 and 24 months) and according to routine clinical practice.
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
- •Subject is ≥18 years of age
- •Subject must be willing to sign a Patient Informed Consent
- •Symptomatic coronary artery disease
- •Subject with a maximum of two single de novo lesions in two different major epicardial vessels
- •Target lesion length ≤ 21 mm by QCA or by visual estimation
- •Target lesion stenosis >50% and <100% by visual estimation, and TIMI flow ≥
- •Subject is eligible for Dual Anti Platelet Therapy (DAPT)
- •Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
排除标准
- •Pregnant and/or breastfeeding females or females who intend to become pregnant during the time of the registry
- •Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum that cannot be adequately pre-medicated
- •Subjects on dialysis
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
- •Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure
- •Heavily calcified or extremely tortuous lesions
- •Bifurcation lesion requiring side branch intervention, if side branches >2 mm in diameter are involved
- •Restenotic target lesion
- •Thrombus in target vessel
- •Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and >20% stenosed lesion by visual estimation) arterial or venous bypass graft
- •Left main coronary artery disease
- •Ostial target lesion (within 5.0 mm of vessel origin)
- •Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
- •Unsuccessful pre-dilatation, defined as residual stenosis rate >20% by visual estimation and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
- •Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
- •Currently participating in another study and primary endpoint is not reached yet
- •Planned interventional treatment of any non-target vessel within 30 days post procedure
- •Planned intervention of the target vessel within 6-month after the index procedure
结局指标
主要结局
Target Lesion Failure at 12 months
时间窗: 12 months
Target Lesion Failure (TLF, a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction, and clinically driven Target Lesion Revascularization) at 12 months
次要结局
- Cardiac death(6, 12 and 24 months post-procedure)
- Target Lesion Failure(6 months and annually thereafter up to 2 years post-procedure)
- Clinically driven Target Lesion Revascularization(6, 12 months and 24 months post-procedure)
- Clinically driven Target Vessel Revascularization(6, 12 months and 24 months post-procedure)
- Target Vessel Myocardial Infarction(6, 12 and 24 months post-procedure)
- Scaffold thrombosis(6, 12 and 24 months post-procedure)
研究者
IGLESIAS Juan Fernando
Medical Doctor, Principal Investigator
University Hospital, Geneva
研究点 (6)
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