PURPOSE: To evaluate the safety and efficacy of a new covered stent, the Cragg Endopro System 1, for intraluminal treatment of peripheral vascular disease in the iliac and femoropopliteal arteries. METHODS: Forty symptomatic patients with predominantly lengthy stenotic (24) or occlusive (13) lesions or aneurysms (3) in the iliac (19), femoral (19), or popliteal (2) arteries were treated percutaneously with balloon angioplasty followed by implantation of the self-expanding nitinol Cragg stent covered by a woven polyester fabric coated with low-molecular-weight heparin. The mean length of femoropopliteal lesions was 13.0 +/- 1.8 cm, as compared to 6.7 +/- 0.8 cm (p < 0.01) for iliac lesions. Mean percent stenosis was 89% +/- 2% with no significant difference between the arterial segments. RESULTS: With a total of 52 covered stents implanted, technical success was achieved in 98% (39/40 patients). One tortuous femoral artery aneurysm was not satisfactorily excluded to prevent leakage. Clinical success was seen in all patients with demonstrable improvements in the claudication stage and the ankle-brachial index from a mean 0.54 to 0.92. Three local complications (one hematoma, two false aneurysms) required surgical repair. One distal embolism, one acute thrombosis, and three subacute thromboses were encountered and successfully treated by thrombolysis and/or surgery. One patient with two iliac stents developed contralateral common iliac artery occlusion from a stent partially obstructing the aorta; placement of a covered stent in the blocked artery re-established normal flow. Over an 8-month follow-up with arteriographic re-examination, all iliac stents remained patent. At the femoropopliteal level, two stents were occluded at 4 months; one was successfully dilated, but the other required surgical bypass grafting. A third patient developed a stenotic lesion proximal to the stent; dilation restored adequate inflow to the stent. CONCLUSIONS: The Cragg Endopro System 1 appears to be effective as an "internal bypass" for iliac and femoropopliteal occlusive disease. More complications and restenosis were seen in femoropopliteal implantations; however, a change in postoperative medication may improve these results. Long-term results will determine if the Cragg Endopro System 1 can achieve a patency equal to conventional bypass grafting.
PURPOSE: To evaluate the safety and efficacy of a new covered stent, the Cragg Endopro System 1, for intraluminal treatment of peripheral vascular disease in the iliac and femoropopliteal arteries. METHODS: Forty symptomatic patients with predominantly lengthy stenotic (24) or occlusive (13) lesions or aneurysms (3) in the iliac (19), femoral (19), or popliteal (2) arteries were treated percutaneously with balloon angioplasty followed by implantation of the self-expanding nitinol Cragg stent covered by a woven polyester fabric coated with low-molecular-weight heparin. The mean length of femoropopliteal lesions was 13.0 +/- 1.8 cm, as compared to 6.7 +/- 0.8 cm (p < 0.01) for iliac lesions. Mean percent stenosis was 89% +/- 2% with no significant difference between the arterial segments. RESULTS: With a total of 52 covered stents implanted, technical success was achieved in 98% (39/40 patients). One tortuous femoral artery aneurysm was not satisfactorily excluded to prevent leakage. Clinical success was seen in all patients with demonstrable improvements in the claudication stage and the ankle-brachial index from a mean 0.54 to 0.92. Three local complications (one hematoma, two false aneurysms) required surgical repair. One distal embolism, one acute thrombosis, and three subacute thromboses were encountered and successfully treated by thrombolysis and/or surgery. One patient with two iliac stents developed contralateral common iliac artery occlusion from a stent partially obstructing the aorta; placement of a covered stent in the blocked artery re-established normal flow. Over an 8-month follow-up with arteriographic re-examination, all iliac stents remained patent. At the femoropopliteal level, two stents were occluded at 4 months; one was successfully dilated, but the other required surgical bypass grafting. A third patient developed a stenotic lesion proximal to the stent; dilation restored adequate inflow to the stent. CONCLUSIONS: The Cragg Endopro System 1 appears to be effective as an "internal bypass" for iliac and femoropopliteal occlusive disease. More complications and restenosis were seen in femoropopliteal implantations; however, a change in postoperative medication may improve these results. Long-term results will determine if the Cragg Endopro System 1 can achieve a patency equal to conventional bypass grafting.