A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 380
- 试验地点
- 17
- 主要终点
- Procedural success rate
研究概览
简要总结
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
详细描述
The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries.
The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.
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 ≥18 years old
- •Subject has provided written informed consent
- •Subject has Rutherford classification 2 to 6
- •Reference vessel diameter ≥2 and ≤7 mm
- •Target lesion(s) has stenosis >70% by visual assessment
- •Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between the lesions will be considered one lesion.
- •For Above the knee (ATK) group
- •Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
- •At least 1 below-knee artery patent to the ankle
- •Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care.
- •For Below the knee (BTK) group:
- •Target lesions involve arteries below the tibial plateau
- •Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications.
排除标准
- •Subject has a single target lesion that involves both ATK and BTK segment.
- •Subject not suitable for receiving endovascular procedures of lower limb arteries
- •Prior planned major amputation in the target limb (above the ankle)
- •Subject with previous bypass surgery of target vessel.
- •History of any open surgical procedure within the past 30 days.
- •Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb. Note: The inflow vessels can be treated on the day of the procedure
- •Subject under dialysis
- •Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached
- •Subject lacking capacity to provide informed consent
- •Subject under judicial protection, tutorship, or curatorship (for France only)
结局指标
主要结局
Procedural success rate
时间窗: Index Procedure
Combination of technical success and absence of procedural complications
次要结局
- Procedure technical success rate(Index Procedure)
- Rate of target lesion bailout stenting(Index Procedure)
- Stented length(Index Procedure)
- Rate of PTA balloon related flow-limiting dissections(Index Procedure)
- Rate of target vessel perforation(Index Procedure)
- Rate of distal embolization(Index Procedure)
- Primary crossing success rate(Index Procedure)
- Rate of target vessel rupture(Index Procedure)
- Rate of acute occlusion(Index Procedure)
- Rate of Serious Adverse Device Effects(Index Procedure)
- Non-labor resource use(Index procedure until discharge)