Claudication, Intermittent, Peripheral Arterial Disease
Conditions
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.
Interventions
PROCEDUREAngioplasty and drug coated balloon of the superficial femoral artery (SFA)
In case of drug coated balloon (DCB) there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA)
PROCEDUREAngioplasty and stenting of the superficial femoral artery (SFA)
In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)
Sponsors
University Hospital, Essen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Vessel stiffness | 6 months Follow Up | Vascular stiffness determined through pulse wave velocity (PWV) |
| Primary patency | 6 months Follow Up | determined through doppler ultrasound |
| 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 |
Countries
Germany
Contacts
Primary ContactChristos Rammos, MD
Backup ContactChristos Rammos
Outcome results
None listed