Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Wound Healing
研究概览
简要总结
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries was terminated. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.
The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.
详细描述
Although the association between the drug coated balloon (DCB) therapy and limb outcomes could not be clearly linked to the use of antiproliferative agents, the findings of paclitaxel crystals downstream of the treated lesions, although in small amounts, has raised concerns about the safety of such therapy in patients with critical limb ischemia (CLI) and tissue loss.
These concerns, however, may not translate to patients with femoropopliteal occlusive disease as the amount of paclitaxel reaching the foot may be even smaller after being filtered by the calf musculature.
Since the use of DCB angioplasty in the Superficial Femoral Artery (SFA) and popliteal has been shown to deliver significantly more durable outcomes compared to standard angioplasty alone, with reported primary patency rates of almost 90% at one year, this therapy may even be more needed in patients with tissue loss where prolonged patency is essential for wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient population: all patients with CLI (critical limb ischemia) and tissue loss scheduled for endovascular intervention for femoral popliteal occlusive or multilevel disease.
- •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
- •Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
- •Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 5 or 6
- •General Angiographic Inclusion Criteria
- •Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in the SFA and/or popliteal arteries.
- •Iliac inflow or Tibial outflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)
排除标准
- •Patient unwilling or unlikely to comply with Follow-Up schedule
- •Aneurysm in the target vessel
- •Acute thrombus in the target limb
- •Sensitivity to Paclitaxel
- •Immunosuppressed patients (transplant, chemotherapy, etc.)
结局指标
主要结局
Wound Healing
时间窗: 12 months
Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.
Amputation Free Survival
时间窗: 6 months
Percentage of participants with a 6 month amputation free survival.
次要结局
- Primary Patency ( Determine if Vessel Remains Open)(6 months)
研究者
Rabih A. Chaer
Professor of Surgery
University of Pittsburgh