Cragg Endopro System I: early experience. I. Femoral arteries.

PURPOSE: This work describes the early experience with the Cragg Endopro System I. The safety and efficacy of this device in the treatment of atherosclerotic lesions of the femoral arteries are evaluated. MATERIALS AND METHODS: Eleven patients with complex femoral artery lesions were treated. Ten patients presented with femoral artery occlusion and one had a 90% stenosis. All patients had life-style limiting claudication. Associated comorbid states included smoking (n = 10), hypertension (n = 4), hyperlipidemia (n = 5), coronary artery disease (n = 3), and diabetes (n = 1). The stents were dilated to the size of the native artery in the first three patients. The protocol was modified and stents were overdilated by 1 mm in the remaining eight patients. An anticoagulation regimen was used in the first three patients and modified per protocol requirements in the remaining eight. Prophylactics antibiotics were given before the procedure. Follow-up studies included Doppler ultrasound and intravenous and intraarterial digital subtraction angiography. RESULTS: An antegrade femoral approach was used. Stent placement was successful in all patients. The mean lesion length was 9.9 cm (4-18 cm). Mean ankle/brachial index before treatment was 0.65 and increased to 0.87 after treatment. Mean follow-up was 17.2 months, and one patients was lost to follow-up. Complications included sepsis (n = 1), fever (n = 2), severe pain (n = 4), thrombosis (n = 5), and hematoma (n = 2). Stent patency was improved after protocol modifications. Overall primary patency rate was 45% and secondary patency was 56%. CONCLUSION: This early experience with the Cragg Endopro System I shows that recanalization of long femoral occlusions and stent-graft placement is feasible. The primary and secondary patency rates are low and the complication rate is high. Improved patency rates are expected with a more aggressive anticoagulation regimen and stent overdilation.