Multicenter trial of the Wallstent in the iliac and femoral arteries

PURPOSE: To report the results of the FDA phase II, multicenter trial of the Wallstent in the iliac and femoral arteries. PATIENTS AND METHODS: Two hundred twenty-five patients entered the trial. Stents were placed in the iliac system in 140 patients and in the femoral systems in 90 (five patients required both iliac and femoral stents). Clinical patency was measured over 2 years by means of life-table analysis with use of clinical and hemodynamic data and the Rutherford scale. Angiographic patency was measured at 6 months. RESULTS: In the iliac system the primary clinical patency was 81% at 1 year and was 71% at 2 years. The secondary clinical patency was 91% and 86%, respectively. The 6-month angiographic patency was 93%. In the femoral system the primary clinical patency was 61% at 1 year and 49% at 2 years. The secondary patency was 84% and 72%, respectively. The 6-month angiographic patency was 80%. CONCLUSIONS: The results are similar to those with the Palmaz stent in the iliac system and with angioplasty alone in the iliac and femoral systems.