Endovascular treatment of peripheral artery disease with expanded PTFE-covered nitinol stents: interim analysis from a prospective controlled study.

Purpose: Current covered peripheral stent designs have significant drawbacks in terms of stent delivery characteristics and flexibility. The aim of this study was to analyze the technical performance, safety and initial clinical efficacy of expanded polytetrafluoroethylene (PTFE)-covered nitinol stents for arteriosclerotic peripheral artery disease. Methods:Eighty-two patients underwent implantation of PTFE-covered nitinol stents for iliac and/or femoral obstructions. The study was conducted prospectively in seven European centers and one Canadian center. Patients were controlled clinically and by duplex ultrasound follow-up. Data up to discharge were collected in 79 patients. Seventy-four patients have thus far received 1 month follow-up and 32 patients, 6 month follow-up examinations. Results: The average lesion length measured 47 mm for the common and external iliac arteries and 50 mm for the femoral arteries. The mean severity of the stenoses was reduced from 94% to 4% in the iliac arteries and from 98% to 7% in the femoral arteries after stent placement and dilatation. One device deviation (inadvertent stent misplacement) and one puncture-related severe adverse event with formation of a pseudoaneurysm occurred. There were occlusions of the stent in five patients. No infections were noticed. Conclusion: The interim analysis of this trial using PTFE-covered nitinol stents indicates thatmore » a strategy using primary implantation of this stent type is technically feasible, has an acceptable safety profile and is effective from a short-term perspective.« less