A Monocenter Randomized Clinical Trial of PAClitaxel drUg-eluting BAlloon Versus Standard Percutaneous Transluminal Angioplasty to Reduce Restenosis in Patients With In-stent Stenoses in the Superficial Femoral and Proximal Popliteal Artery
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- primary patency rate
研究概览
简要总结
Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms:
- Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)
- Control Arm: standard percutaneous transluminal angioplasty (sPTA).
Purpose:
To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).
详细描述
Introduction
Restenosis after endovascular stenting with nitinol stents occurs in up to 30% of the patients at 12 months and up to 50% at 24 months. The rate of recurrence after repeated treatment of SFA in-stent restenoses ranges up to 70% at 6 months.
A recent clinical trial suggested significant inhibition of re-restenosis after treatment of restenosis in coronary stents by Paclitaxel-coated angioplasty balloons.
Study Design
Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All criteria 1-6 should apply for inclusion.
- •Age > 50 years
- •Patient legally authorized to provide written informed consent
- •Patient willing and likely to comply with the follow up schedule
- •Patient symptomatic Rutherford-Becker 2-5 (Fontaine II-IV)
- •In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA)
- •Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA
排除标准
- •Patients unable to give informed consent
- •Patients enrolled in another study with any investigational drug or device
- •Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study
- •Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel
- •Life expectancy of < 1 years
结局指标
主要结局
primary patency rate
时间窗: 6 months
Primary patency at 6 month follow up, defined as \<50%\* diameter stenosis as demonstrated by CDUS and CTA in the absence of clinically driven TLR (Target Lesion Revascularization) during follow-up. Clinically driven TLR defined as reintervention of the target lesion due to presence of a symptomatic \>50%\* diameter stenosis.
次要结局
- severe adverse events(30 day)