Nitinol intravascular stent: results of preclinical evaluation.
OBJECTIVE
To test an expandable nitinol intraluminal stent for hoop strength, biocompatibility, corrosion resistance, and patency.


METHODS
Forty-four stents were implanted in the iliac arteries of 22 sheep. Follow-up was performed with angiography and histologic examination for up to 6 months.


RESULTS
All but one stent remained widely patent during the follow-up period. Two stents in two sheep were placed incorrectly early in the study; these sheep were not followed up. Hoop strength was found to be superior to that of a similar, commercially available, self-expanding stent. Minimal corrosion was seen at 6 months, and the stent appears to be biocompatible. The stent has good radiopacity and deploys with minimal foreshortening.


CONCLUSIONS
The stent can be reliably and safely deployed in the vascular system. Clinical trials in humans are warranted.
Cragg
A H
AH
Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City.
De Jong
S C
SC
Barnhart
W H
WH
Landas
S K
SK
Smith
T P
TP
D000497:Alloys; D000792:Angiography; D000818:Animals; D001672:Biocompatible Materials; D003343:Corrosion; D004867:Equipment Design; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging; D007083:Iliac Artery / Q000000981:diagnostic imaging; D012756:Sheep; D015607:Stents; D013314:Stress, Mechanical; D014654:Vascular Patency / Q000502:physiology
D000497:Alloys; D001672:Biocompatible Materials; C013616:nitinol