Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 over 18 years with critical lower limb ischemia,
- •Ruhtherford 3 or higher,
- •with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,
- •with a maximum extension of 10 cm stenosis.
- •The popliteal artery and at least one leg artery must be patent.
排除标准
- •Pregnancy,
- •thrombophilia,
- •coagulation disorders,
- •presence of active or recent bleeding,
- •severe allergy to iodinated contrast,
- •renal or hepatic disease,
- •acute limb ischemia,
- •prior surgical bypass or angioplasty (with or without stent) on the target artery,
- •obstructive disease (stenosis> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)
研究组 & 干预措施
Drug Eluting Balloon
Admiral In.Pact Drug Eluting Balloon
干预措施: Drug Eluting Balloon Angioplasty (Device)
Nitinol Stent
Complete SE Self-expandible Nitinol stent
干预措施: Nitinol stenting (Device)
结局指标
主要结局
Primary patency
时间窗: 12 months
Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%
次要结局
- Acute myocardial infarct(12 months)
- Death(12 months)
- Ankle braquial Index(12 months)
- Target Lesion Revascularization(12 months)
- Rutherford classification(12 months)
- Stent fracture(12 months)
- Amputation(12 months)
研究者
Fabio H Rossi
MD, PHD
Instituto Dante Pazzanese de Cardiologia