A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioMatrix AlphaTM (Cobalt Chromium Biolimus A9TM Drug-eluting Stent) - ALPHA LONG Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 15
- 主要终点
- Number of participants with Target Lesion Failure (TLF)
研究概览
简要总结
Prospective, multi-center, open-label single-arm study designed to enroll 85 patients in up to 15 centers in up to 3 European countries.
All patients will be followed up for 9 months. The "BMX Alpha Registry" study will serve as reference and historic comparator.
详细描述
The objective of this study is to evaluate if PCI performed using the additional sizes of the BioMatrix AlphaTM stent results in similar safety and efficacy outcomes as the currently approved (CE marked) sizes of BioMatrix Alpha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must provide written informed consent
- •Patient is at least 18 years old
- •Patients scheduled to undergo PCI of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device
- •Patients who agree to comply with the follow up requirements
- •Patients with a life expectancy of > 1 year at time of consent
- •Patients eligible to receive for ≥6 months either dual anti-platelet therapy (DAPT, i.e. 75 mg clopidogrel or another P2Y12 inhibitor per choice of the investigator, and 75-100 mg aspirin) or a combination of an oral anti-coagulant (Vitamin K antagonist or novel anti-coagulant) and a single anti-platelet agent
- •Hemodynamically stable patients
排除标准
- •Inability to provide informed consent
- •Currently participating in another clinical trial
- •Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
- •Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
- •Patients with a life expectancy of < 1 year
- •Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
结局指标
主要结局
Number of participants with Target Lesion Failure (TLF)
时间窗: at 9 months after index procedure
Primary endpoint is the rate of Target Lesion Failure (TLF) at 9 months defined as cardiovascular death or target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR)
次要结局
- Number of participants with Target Vessel Myocardial Infarction(at 9 months after index procedure)
- Number of participants with Stent thrombosis (definite and/or probable)(at 9 months after index procedure)
- Number of participants with Clinically indicated Target Lesion Revascularization(at 9 months after index procedure)
- Number of participants with Target Vessel Revascularization(at 9 months after index procedure)
- Number of participants with Cardiovascular Death (CD)(at 9 months after index procedure)
- Number of of participants with All-cause mortality(at 9 months after index procedure)