The purpose of this study is to evaluate the effectiveness of the covered stent Viabahn in treating long de novo femoropopliteal lesions (stenosis ≥ 25 cm, total occlusion ≥ 15 cm) or in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.
This is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. Approximately 200 subjects will be enrolled into a Viabahn group (observe arm) or drug-coated balloons (DCB) group (contrast arm); Each group will include 100 patients. All enrolled patients will be followed up for 12 and 24 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, 3,6 and 9 months.
Study Type
OBSERVATIONAL
Enrollment
200
Viabahn endoprosthesis group: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.
Primary patency
Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Time frame: 12-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: 12-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: 12-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: 12-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: 12-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: 12-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: 12-month
Vasc quality of life score
Change of Vasc quality of life score
Time frame: 12-month