Palmaz vascular stent: initial clinical experience.

The safety and efficacy of the Palmaz balloon-expandable vascular stent and its effect on the results of percutaneous transluminal angioplasty (PTA) were assessed in a prospective study. Technical success was achieved in the placement of 34 of 35 stents (97%) in 27 common and external iliac artery lesions in 19 patients (23 limbs) who presented with disabling claudication, rest pain, or gangrene. Stent placement improved the angiographic results achieved by PTA alone in all 19 patients. Seventeen of 23 limbs (74%) had significant (greater than 20%) elevation of the ankle-arm index after combined angioplasty and stent placement, including nine limbs with occlusive outflow lesions. All 10 patients with continuous runoff distal to the stent and one patient with discontinuous runoff had resolution of their symptoms, remaining unchanged at a mean follow-up time of 6 months. There were three complications: One significantly altered the patient's hospital course, but none detracted from the achieved stent result. Stent placement is effective and does not significantly increase the complication rate of conventional iliac PTA. The current delivery system, however, may limit its utility.