CRAGG ENDOPRO SYSTEM-I - EARLY EXPERIENCE .1. FEMORAL ARTERIES

PURPOSE: This work describes the early experience with the Cragg Endop ro System I. The safety and efficacy of this device in the treatment o f atherosclerotic lesions of the femoral arteries are evaluated. MATER IALS 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 claudica tion, Associated comorbid states included smoking (n = 10), hypertensi on (n = 4), hyperlipidemia (n = 5), coronary artery disease (n = 3), a nd diabetes (n = 1), The stents were dilated to the size of the native artery in the first three patients, The protocol was modified and ste nts were overdilated by 1 mm in the remaining eight patients, An antic oagulation regimen was used in the first three patients and modified p er protocol requirements in the remaining eight, Prophylactic antibiot ics were given before the procedure, Follow-up studies included Dopple r ultrasound and intravenous and intraarterial digital subtraction ang iography. RESULTS: An antegrade femoral approach was used, Stent place ment 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 in creased to 0.87 after treatment, Mean follow-up was 17.2 months, and o ne patient was lost to follow-up, Complications included sepsis (n = 1 ), fever (n = 2), severe pain (n = 4), thrombosis (n = 5), and hematom a (n = 2), Stent patency was improved after protocol modifications, Ov erall primary patency rate was 45% and secondary patency was 56%. CONC LUSION: This early experience with the Cragg Endopro System I shows th at 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.