Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- local endothelial function
研究概览
简要总结
Endovascular treatment of the superficial femoral artery has a high initial success rate, but restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved, interventional strategies affect endothelial function. Endothelial dysfunction is the pathophysiologic principle involved in the initiation and progression of arteriosclerosis.
The aim of this study is to determine the impact of endovascular strategies in the superficial femoral artery on local and systemic endothelial and vascular function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4, or 5
- •Planed peripheral intervention TASC A-C
- •Subject must be between 40 and 85 years old
- •Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
- •Guidewire must cross lesion(s) within the true lumen, without a relevant sub-intimal course
- •Vessel diameter ≥3.0 mm and ≤6.0 mm
- •Willing to comply with the specified follow-up evaluation
- •Written informed consent prior to any study procedures
排除标准
- •Lesions TASC D
- •Angiographic evidence of thrombus within target vessel
- •Thrombolysis within 72 hours prior to the index procedure
- •Aneurysm in the femoral artery or popliteal artery
- •Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- •Unstable angina pectoris at the time of the enrollment
- •Recent myocardial infarction or stroke < 30 days prior to the index procedure
- •Life expectancy less than 12 months
- •Septicemia at the time of enrollment
- •Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- •Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
- •Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
研究组 & 干预措施
DCB
干预措施: Angioplasty and drug coated balloon of the superficial femoral artery (SFA) (Procedure)
Stenting
干预措施: Angioplasty and stenting of the superficial femoral artery (SFA) (Procedure)
结局指标
主要结局
local endothelial function
时间窗: 6 months Follow Up
Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)
次要结局
- Systemic endothelial function(6 months Follow Up)
- target lesion revascularization(6 months Follow Up)
- ABI (Ankle Brachial Index)(6 months Follow Up)
- Primary patency(6 months Follow Up)
- Vessel stiffness(6 months Follow Up)
研究者
Fadi Al-Rashid
Principal Investigator
University Hospital, Essen