SFA TReatment and vAscular Functions
- Conditions
- Peripheral Arterial DiseaseClaudication, Intermittent
- Interventions
- Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA)Procedure: Angioplasty and stenting of the superficial femoral artery (SFA)
- Registration Number
- NCT03811925
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCB Angioplasty and drug coated balloon of the superficial femoral artery (SFA) - Stenting Angioplasty and stenting of the superficial femoral artery (SFA) -
- Primary Outcome Measures
Name Time Method local endothelial function 6 months Follow Up Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)
- Secondary Outcome Measures
Name Time Method Systemic endothelial function 6 months Follow Up 1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
target lesion revascularization 6 months Follow Up freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
ABI (Ankle Brachial Index) 6 months Follow Up Ankle Brachial Index assessed by Doppler
Primary patency 6 months Follow Up determined through doppler ultrasound
Vessel stiffness 6 months Follow Up Vascular stiffness determined through pulse wave velocity (PWV)
Trial Locations
- Locations (1)
University Hospital Essen
🇩🇪Essen, NRW, Germany