Initial and mid-term results of a 4F compatible self-expanding low strut profile nitinol stent in the superficial femoral artery.
OBJECTIVE
To evaluate the initial and mid-term results of a new self-expanding low strut profile nitinol stent for treatment of atherosclerotic lesions stenoses and occlusions in the superficial femoral artery (SFA).


METHODS
In 8 patients (4 male, 4 female, mean age 74.8 +/- 8.8 years) with SFA lesions and non-satisfying results after PTA treatment alone, 10 self-expanding nitinol Xpert stents were deployed via a 4 F sheath. Stent characteristics and handling were graded by the interventionalist. Fontaine classification, duplex flow measurements and ankle brachial index (ABI) at rest and stress were taken prior and one day after stent placement. Patients were followed 3, 6 and 12 months after the procedure obtaining the same parameters at each appointment.


RESULTS
Initial stent treatment was successful in all patients. Stent handling and positioning were rated very good and safe. All patients improved clinically by at least one Fontaine stage (range before treatment: stage IIb to IV). The mean ABI at rest (stress) improved initially from 0.68 (0.70) to 1.07 (0.99). During a mean follow-up period of 8.3 months no case of clinically relevant in-stent stenosis was observed with stable values of ABI at rest and stress.


CONCLUSIONS
Treatment of SFA lesions using the 4F-compatible self-expanding nitinol Xpert stent is technically simple, safe and shows good initial and mid-term results.
Mühlenbruch
G
G
Klinik für Radiologische Diagnostik, Universitätsklinikum der RWTH-Aachen, Pauwelsstrasse 30, 52057 Aachen, Germany. gmuehlen@rad.rwth-aachen.de
Brock
H
H
Das
M
M
Hohl
C
C
Mahnken
A H
AH
Wildberger
J
J
Günther
R W
RW
Haage
P
P
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D050197:Atherosclerosis / Q000000981:diagnostic imaging / Q000628:therapy*; D015331:Cohort Studies; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D015607:Stents
D000497:Alloys; C013616:nitinol