Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.
Keywords: balloon angioplasty; bare metal stent; dissection; patency; peripheral artery disease; popliteal artery; recoil; stent; superficial femoral artery; target lesion revascularization.