Status:
UNKNOWN
SFA TReatment and vAscular Functions
Lead Sponsor:
University Hospital, Essen
Conditions:
Peripheral Arterial Disease
Claudication, Intermittent
Eligibility:
All Genders
40-85 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03811925
Start Date
June 1 2018
End Date
July 1 2019
Last Update
January 22 2019
Active Locations (1)
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1
University Hospital Essen
Essen, North Rhine-Westphalia, Germany, 45122