The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.
This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.
Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.
Renji Hospital
Shanghai, Shanghai Municipality, China
Primary patency
Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Time frame: 24-month
Freedom from a composite of Major adverse events (MAEs)
Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death
Time frame: 24-month
Procedural success
Procedural success is defined as technical or device success without major adverse events during the hospital stay.
Time frame: Immediately after interventional surgery
Primary assisted patency
Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.
Time frame: 24-month
Secondary patency
Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Time frame: 24-month
Clinically-driven target vessel revascularization (CD-TVR)
clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study.
Time frame: 24-month
Primary sustained clinical improvement
Defined as a sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.
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Time frame: 24-month
Secondary sustained clinical improvement
Defined as a sustained upward shift of at least one category on the Rutherford classification3, including the need for repeated target lesion revascularization (TLR) in surviving patients.
Time frame: 24-month
Vasc quality of life score
Change of Vasc quality of life score
Time frame: 24-month