SFA TReatment and vAscular Functions (STRAtiFy)

University Hospital Essen

Status

Unknown

Conditions

Claudication, Intermittent

Peripheral Arterial Disease

Treatments

Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA)

Procedure: Angioplasty and stenting of the superficial femoral artery (SFA)

Study type

Interventional

Funder types

Other

Identifiers

NCT03811925

STRAtiFy_CR

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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