Endovascular stent-grafts for superficial femoral artery disease: results of 1-year follow-up.
OBJECTIVE
To document a preliminary study to assess the deployment and outcomes of endoluminal stent grafting in the superficial femoral artery (SFA) with use of a prototype device.


METHODS
Twenty patients with lifestyle-limiting intermittent claudication were selected for treatment with a balloon-mounted expansive polytetrafluoroethylene graft. All patients had angiographically proven SFA disease (median length, 17 cm) with normal arterial inflow and at least two calf vessels patent to the ankle. Follow-up was by means of ankle brachial pressure index (ABPI), duplex ultrasound, and angiography.


RESULTS
Fourteen patients were successfully treated. Six patients were excluded: five by the study protocol and one because the procedure was a technical failure. ABPI rose from 0.6 before treatment to 1.0. The treated limbs became asymptomatic. Twelve-month primary, primary assisted, and secondary patency rates of treated patients were 29%, 50%, and 64%.


CONCLUSIONS
Endovascular stent grafting of SFA lesions is technically feasible, but the patency rates obtained with this design are inferior to those obtained with conventional surgical bypass.
Kessel
D O
DO
Department of Radiology, St. James's University Hospital, Leeds, UK.
Wijesinghe
L D
LD
Robertson
I
I
Scott
D J
DJ
Raat
H
H
Stockx
L
L
Nevelsteen
A
A
D000368:Aged; D000497:Alloys; D015901:Angiography, Digital Subtraction; D001672:Biocompatible Materials; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011183:Postoperative Complications; D011474:Prosthesis Design; D055502:Secondary Prevention; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D000497:Alloys; D001672:Biocompatible Materials; C013616:nitinol; D011138:Polytetrafluoroethylene