Clinical trial NCT03811925: SFA TReatment and vAscular Functions
Official title: Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication, Intermittent
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: local endothelial function
timeFrame: 6 months Follow Up
Secondary outcomes:
measure: Systemic endothelial function
timeFrame: 6 months Follow Up
measure: Vessel stiffness
timeFrame: 6 months Follow Up
measure: Primary patency
timeFrame: 6 months Follow Up
measure: target lesion revascularization
timeFrame: 6 months Follow Up
measure: ABI (Ankle Brachial Index)
timeFrame: 6 months Follow Up
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
References: