The Nitinol SMART stent vs Wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results.
OBJECTIVE
The Cordis Randomized Iliac Stent Project-US (CRISP-US) trial evaluated, with an equivalence design, the performance of the shape memory alloy recoverable technology (SMART) nitinol self-expanding stent and the stainless steel Wallstent for treating iliac artery disease after suboptimal percutaneous transluminal angioplasty (PTA).


METHODS
This multicenter, prospective, randomized trial comprised 203 patients with chronic limb ischemia who received either the SMART stent (n = 102) or the Wallstent (n = 101) after suboptimal PTA. The primary equivalence end point was a composite of 9-month restenosis, 30-day death, and 9-month target vessel revascularization. Functional, clinical, and hemodynamic assessments were made at hospital discharge and at 1, 6, 9, and 12 months.


RESULTS
The 9-month composite end point rate was equivalent for the SMART stent and Wallstent (6.9% vs 5.9%), with low rates of restenosis (3.5% vs 2.7%), death (2.0% vs 0.0%), and revascularization (2.0% vs 4.0%) in the two groups. Primary patency at 12 months was 94.7% and 91.1% with the SMART stent and Wallstent, respectively. Functional and hemodynamic improvement was also comparable between the groups. The acute procedural success rate was higher in the SMART stent group (98.2% vs 87.5%; P =.002). The frequency of major adverse events was similar at 1 year (4.9% vs 5.9%).


CONCLUSIONS
The performance of the SMART stent was equivalent to that of the Wallstent for treating iliac artery stenosis. The design characteristics of the SMART stent may contribute to greater procedural success and more accurate stent deployment.
Ponec
Donald
D
Department of Radiology, Tri City Medical Center, 4002 Vista Way, Oceanside, CA 92056, USA. ponecdj@tcmc.com
Jaff
Michael R
MR
Swischuk
James
J
Feiring
Andy
A
Laird
John
J
Mehra
Munish
M
Popma
Jeffrey J
JJ
Donohoe
Dennis
D
Firth
Brian
B
Keim
Emily
E
Snead
David
D
D000368:Aged; D000497:Alloys; D000792:Angiography; D017130:Angioplasty; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D005260:Female; D006801:Humans; D007083:Iliac Artery; D008297:Male; D012449:Safety; D015607:Stents
D000497:Alloys; C013616:nitinol