Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis \>10cm, occlusions \>5cm).
Prospective, multi-center 1:1 randomized Study. Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm) In total 120 patient will be enrolled in this study, each strata will include 60 patients. All enrolled patients will be followed up for 24 month to asses the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36, 48 and 60 month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
University Clinic Leipzig
Leipzig, Saxony, Germany
Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound
Time frame: 1 Year
Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24
The graded score is multiplied by a pre-specified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks)
Time frame: 2 Year
Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month
The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 considered normal (free from significant PAD), while a lesser than 0.9 indicates arterial disease
Time frame: 2 Year
Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month
This classification system consists of four grades and seven categories (categories 0-6): Grade 0, Category 0: asymptomatic Grade I, Category 1: mild claudication Grade I, Category 2: moderate claudication Grade I, Category 3: severe claudication Grade II, Category 4: rest pain Grade III, Category 5: minor tissue loss; ischemic ulceration not exceeding ulcer of the digits of the foot Grade IV, Category 6: major tissue loss; severe ischemic ulcers or frank gangrene
Time frame: 2 Year
Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization
Time frame: 5 Years
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