CIVILIAN Study in Femoropopliteal Artery Occlusion Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Major adverse event
研究概览
简要总结
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.
详细描述
Femoropopliteal artery occlusive disease is a common type of peripheral arterial disease (PAD). Hitherto, endovascular treatment has been testified and advocated as the first-line treatment of femoropopliteal occlusive disease. However, the in-stent restenosis has been a major limitation of well long-term patency rate in this segment due to physiological and geometrical issues. The concept "leave nothing behind" is proposed, and some vessel preparation methods and devices, such as directional atherectomy, rotational atherectomy, laser atherectomy are developed. This is a national, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions. A total of 1000 patients will be included in approximately 8 sites. The study is designed to demonstrate the inferiority of different vessel preparation strategies in various fields under long-term follow-up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
- •Patient has a score from 2 to 5 following Rutherford classification
- •Unilateral or bilateral F-P occlusive lesions (enrollment of one or both target limbs depend on operators)
- •Complete recanalization followed by POBA, Chocolate PTA, Scoring PTA, Shockwave PTA, SilverHawk, TurboHawk, Jetstream, Angiojet, Laser and Rotarex
- •Angiographic Inclusion Criteria:
- •TASC II-Type A/B/C/D
- •Iliac inflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)-less than 50% residual stenosis
- •There is angiographic evidence of at least one-vessel-runoff (>10cm) to the foot
排除标准
- •Projected for major amputation of target limb (above ankle joint)
- •Change to thrombectomy or bypass during operation
- •Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated
- •Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
- •female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
- •Life expectancy of less than twelve months.
- •Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
- •Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
- •Patient unwilling or unlikely to comply with Follow-Up schedule
- •Angiographic Exclusion Criteria:
- •Testified for acute F-P arterial embolization
- •Thromboangiitis obliterans
- •Failed for recanalization
结局指标
主要结局
Major adverse event
时间窗: within 12 months post-procedure
Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality
Freedom from TLR
时间窗: within 12 months post-procedure
Percentage of participants with a 1-year TLR free survival
Incidence of complications
时间窗: immediately following procedure (day 30)
Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure
次要结局
- Amputation Free Survival(within 12 months post-procedure)
- Numbers of patients with Primary patency(within 3, 6, 12 months post-procedure)
- Technical Success(within 24 hours post-procedure)
- Incidence of Bailout stenting(immediately following vessel preparation and DCB angioplasty)
- Incidence of dissection and types(immediately following vessel preparation)
- Improvement of ABI(within 3, 6, 12 months post-procedure)
- Improvement of related symptoms(within 3, 6, 12 months post-procedure)
研究者
Bo Yu, MD
Professor
Shanghai Pudong Hospital