PMCF Registry Study Paclitaxel-eluting Balloon Catheter Support C
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- OrbusNeich
- 入组人数
- 282
- 试验地点
- 12
- 主要终点
- Adjudicated, device-oriented, Target Lesion Failure (TLF)
研究概览
简要总结
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.
详细描述
This multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.
A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.
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
- •Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
- •In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule.
- •If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry.
排除标准
- •Patients are excluded if ANY of the following additional conditions apply:
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
- •A life expectancy of <1year
- •Explicit refusal of participation in the registry
研究组 & 干预措施
Drug Eluting SUPPORT C PTCA balloon catheter
The Drug Eluting SUPPORT C PTCA balloon catheter is indicated for use in patients with symptomatic ischaemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses.
结局指标
主要结局
Adjudicated, device-oriented, Target Lesion Failure (TLF)
时间窗: 12 months post procedure
Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI), or clinically driven target lesion revascularization (cd-TLR) (by PCI or coronary artery bypass grafting).
次要结局
- Adjudicated Target Lesion Failure (TLF)(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 24 months, and 36 months)
- Each of the components of TLF (cardiac death (CD), non-fatal myocardial infarction not clearly attributable to a non-target vessel (TV-MI), and clinically driven target lesion revascularization (cd-TLR) )(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated Target Vessel Failure (TVF) a composite of all Cardiovascular Death (CVD), TV-MI, and clinically driven Target Vessel Revascularization (cd-TVR)(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Each of the components of TVF (Cardiovascular Death (CVD), TV-MI, and clinically driven Target Vessel Revascularization (cd-TVR) )(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated stroke(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated lesion thrombosis(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Device success(Index Procedure)
- Procedure success(Index Procedure)