A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
47
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Target Lesion Revascularization
Effectiveness: Target Lesion Revascularization at 1 Year: TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)
Time frame: 1 year
Major Adverse Events
Safety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting)
Time frame: 30 Days
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