Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 911-918 |
| Number of pages | 8 |
| Journal | Journal of Vascular and Interventional Radiology |
| Volume | 15 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 2004 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Radiological and Ultrasound Technology
Cite this
The nitinol SMART stent vs wallstent for suboptimal iliac artery angioplasty : CRISP-US trial results. / Ponec, Donald; Jaff, Michael R.; Swischuk, James; Feiring, Andy; Laird, John; Mehra, Munish; Popma, Jeffrey J.; Donohoe, Dennis; Firth, Brian; Keim, Emily; Snead, David.
In: Journal of Vascular and Interventional Radiology, Vol. 15, No. 9, 09.2004, p. 911-918.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The nitinol SMART stent vs wallstent for suboptimal iliac artery angioplasty
T2 - CRISP-US trial results
AU - Ponec, Donald
AU - Jaff, Michael R.
AU - Swischuk, James
AU - Feiring, Andy
AU - Laird, John
AU - Mehra, Munish
AU - Popma, Jeffrey J.
AU - Donohoe, Dennis
AU - Firth, Brian
AU - Keim, Emily
AU - Snead, David
PY - 2004/9
Y1 - 2004/9
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=4544368741&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=4544368741&partnerID=8YFLogxK
U2 - 10.1097/01.RVI.0000140935.45313.35
DO - 10.1097/01.RVI.0000140935.45313.35
M3 - Article
C2 - 15361558
AN - SCOPUS:4544368741
VL - 15
SP - 911
EP - 918
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
SN - 1051-0443
IS - 9
ER -