A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
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
- 283
- 试验地点
- 20
- 主要终点
- Proportion of participants with Adjudicated freedom from major adverse events (MAE)
研究概览
简要总结
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the Instructions for Use and treating physician decision. Data will be collected in order to assess the long-term safety and performance of the VITUS peripheral drug-coated dilatation catheter in routine clinical practice.
详细描述
The multicenter, prospective registry population consists of consecutive patients with peripheral arterial occlusive disease (PAOD) who undergo percutaneous transluminal angioplasty (PTA) intervention and are intended to be or treated by the VITUS peripheral drug-coated dilatation catheter (according to the Instructions for Use) as part of routine clinical care. Approximately 284 patients from approximately 15 centers in Europe will be entered into the registry. Patients entered into 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, and 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 the VITUS peripheral drug-coated dilatation catheter as per physicians' decision and according to IFU in the setting of routine clinical care are entered into the registry
- •The lesion to be treated should be shorter than the nominal length of balloon at a reference vessel diameter of 2.0 mm up to 7.0 mm.
- •If lesion is longer than the individual balloon, more than one DCB can be used for longer lesions with the mandatory overlapping balloons of 10mm to avoid any geographical miss.
- •Rutherford clinical categories 2-5
排除标准
- •The patients are excluded from registration if ANY of the following 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 in peripheral arteries is planned
- •A life expectancy of <1year
- •Explicit refusal of participation in the registry
- •Residual stenosis >50% after vessel preparation
研究组 & 干预措施
VITUS peripheral drug-coated dilatation catheter
The VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD).
干预措施: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon (Device)
结局指标
主要结局
Proportion of participants with Adjudicated freedom from major adverse events (MAE)
时间窗: 12 months post-procedure (primary safety and efficacy endpoint at 12 months)
Adjudicated freedom from MAE, where MAE is defined as a composite of device- and procedure-related mortality through 30 days, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (cd-TLR) within 12 months
Occurrence of Adjudicated freedom from cd-TLR
时间窗: 12 months post-procedure (primary efficacy endpoint at 12 months)
Adjudicated freedom from cd-TLR, where cd-TLR is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms
Proportion of participants with Adjudicated freedom from major adverse events (MAE)
时间窗: 30 days post-procedure (primary safety endpoint at 30 days)
Adjudicated freedom from major adverse events (MAE), where MAE is defined as a composite of device- and procedure-related mortality, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (cd-TLR)
次要结局
- Proportion of participants with Adjudicated freedom from MAE(through hospital discharge (expected to be within 24 hours), 6 months, 12 months, 24 months and 36 months)
- Occurrence of Adjudicated freedom from cd-TLR(through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 24 months and 36 months)
- Occurrence of Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)(through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months)
- Proportion of participants with Major amputation-free survival(through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months)
- Proportion of participants with Any amputation-free survival(through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months)
- Change in Rutherford clinical category(12 months)
- Change in Walking Impairment Questionnaire (WIQ) results(12 months, 24 months, and 36 months)
- Proportion of participants with Primary patency(12 months, 24 months, and 36 months)
- Proportion of participants with Device Success(Peri-procedural)
- Proportion of participants with Procedure Success(Peri-procedural)
- Quality of Life Assessment(12 months)
- Proportion of participants with Adjudicated freedom from MAE(6 months)