Multicenter trial of the Jostent balloon-expandable stent-graft in renal and iliac artery lesions

Purpose: To report the results of a multicenter feasibility study of the Jostent balloon-expandable stent-graft in the treatment of renal and iliac artery lesions. Methods: Twenty-three patients (17 men; mean age 62 years, range 38-80) with lesions in the renal (n=12) or iliac arteries (n=12) were enrolled in 6 centers over a 1-year period. Preprocedural computed tomography (CT) and angiography were performed in all patients. The Jostent device was implanted in the 24 arteries to treat 11 in-stent stenoses, 2 arterial ruptures, 2 aneurysms, 2 dissections, 2 ulcerated stenoses, and 5 chronic occlusions. Follow-up included color duplex ultrasound examination on the day after the procedure and at 6 months; patients with renal artery stent-grafts were also evaluated with CT angiography. Results: Twenty-seven stent-grafts were deployed successfully in the 24 (100%) arteries. Seven (30%) patients required adjunctive procedures to address 1 acute in-stent thrombosis, 2 dissections, and 4 in-stent residual stenoses. At 6-month follow-up, 2 (8.3%) restenoses occurred in the renal arteries; these were treated successfully using balloon angioplasty. Conclusions: These data suggest that a balloon-expandable stent-graft may be safe and useful in patients with selected peripheral indications.