The nitinol SMART stent vs wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results

Donald Ponec, Michael R. Jaff, James Swischuk, Andy Feiring, John Laird, Munish Mehra, Jeffrey J. Popma, Dennis Donohoe, Brian Firth, Emily Keim, David Snead

Research output: Contribution to journalArticle

75 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)911-918
Number of pages8
JournalJournal of Vascular and Interventional Radiology
Volume15
Issue number9
DOIs
StatePublished - Sep 2004
Externally publishedYes

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Iliac Artery
Angioplasty
Stents
Technology
Hemodynamics
nitinol
Stainless Steel
Pathologic Constriction
Ischemia
Extremities

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 journalArticle

Ponec, D, Jaff, MR, Swischuk, J, Feiring, A, Laird, J, Mehra, M, Popma, JJ, Donohoe, D, Firth, B, Keim, E & Snead, D 2004, 'The nitinol SMART stent vs wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results', Journal of Vascular and Interventional Radiology, vol. 15, no. 9, pp. 911-918. https://doi.org/10.1097/01.RVI.0000140935.45313.35
Ponec, Donald ; Jaff, Michael R. ; Swischuk, James ; Feiring, Andy ; Laird, John ; Mehra, Munish ; Popma, Jeffrey J. ; Donohoe, Dennis ; Firth, Brian ; Keim, Emily ; Snead, David. / The nitinol SMART stent vs wallstent for suboptimal iliac artery angioplasty : CRISP-US trial results. In: Journal of Vascular and Interventional Radiology. 2004 ; Vol. 15, No. 9. pp. 911-918.
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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.",
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T1 - The nitinol SMART stent vs wallstent for suboptimal iliac artery angioplasty

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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

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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.

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