Document Detail

The Nitinol SMART stent vs Wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results.
MedLine Citation:
PMID:  15361558     Owner:  NLM     Status:  MEDLINE    
PURPOSE: 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). MATERIALS AND 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.
Donald Ponec; Michael R Jaff; James Swischuk; Andy Feiring; John Laird; Munish Mehra; Jeffrey J Popma; Dennis Donohoe; Brian Firth; Emily Keim; David Snead;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of vascular and interventional radiology : JVIR     Volume:  15     ISSN:  1051-0443     ISO Abbreviation:  J Vasc Interv Radiol     Publication Date:  2004 Sep 
Date Detail:
Created Date:  2004-09-13     Completed Date:  2004-12-29     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9203369     Medline TA:  J Vasc Interv Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  911-8     Citation Subset:  IM    
Department of Radiology, Tri City Medical Center, 4002 Vista Way, Oceanside, CA 92056, USA.
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MeSH Terms
Arterial Occlusive Diseases / therapy*
Iliac Artery*
Reg. No./Substance:
0/Alloys; 52013-44-2/nitinol
Comment In:
J Vasc Interv Radiol. 2004 Sep;15(9):907-9   [PMID:  15361557 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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