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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Study design and rationale of the ‘Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial’: study protocol for a randomized controlled trial

Authors: Woong Gil Choi, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Ae Yong Hur, Young Guk Ko, Sang Min Park, Ki Chang Kim, Joo Han Kim, Min Woong Kim, Sang Min Kim, Jang Ho Bae, Jung Min Bong, Won Yu Kang, Jae Bin Seo, Woo Yong Jung, Jang Hyun Cho, Do Hoi Kim, Ji Hoon Ahn, Soo Hyun Kim, Ji Yong Jang, SENS-ILIAC Investigators

Published in: Trials | Issue 1/2016

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Abstract

Background

The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease.

Methods/design

The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound.

Discussion

The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions.

Trial registration

National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495), registration date: May 8, 2012
Appendix
Available only for authorised users
Literature
1.
Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005;41:423–35.CrossRefPubMed
2.
Timaran CH, Prault TL, Stevens SL, Freeman MB, Goldman MH. Iliac artery stenting versus surgical reconstruction or TASC (TransAtlantic Inter-Society Consensus) type B and type C iliac lesions. J Vasc Surg. 2003;38:272–8.CrossRefPubMed
3.
Schurmann K, Mahnken A, Meyer J, Haage P, Chalabi K, Peters I, Günther RW, Vorwerk D. Long-term results 10 years after iliac arterial stent placement. Radiology. 2002;224:731–8.
4.
Murphy TP, Ariaratnam NS, Carney WI, Marcaccio EJ, Slaiby JM, Soares GM, Kim HM. Aortoiliac insufficiency: long-term experience with stent placement for treatment. Radiology. 2004;231:243–9.
5.
Klein WM, van der Graaf Y, Seegers J, Spithoven JH, Buskens E, van Baal JG, Buth J, Moll FL, Overtoom T T, van Sambeek MR, Mali WP. Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement. Radiology. 2006;238:734–44.
6.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–67.
7.
Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology. 1997;204:87–96.CrossRefPubMed
8.
Hood DB, Hodgson KJ. Percutaneous transluminal angioplasty and stenting for iliac artery occlusive disease. Surg Clin North Am. 1999;79:575–96.CrossRefPubMed
9.
Powell RJ, Fillinger M, Walsh DB, Zwolak R, Cronenwett JL. Predicting outcome of angioplasty and selective stenting of multisegment iliac artery occlusive disease. J Vasc Surg. 2000;32:564–9.CrossRefPubMed
10.
Powell RJ, Fillinger M, Bettmann M, Jeffery R, Langdon D, Walsh DB, Zwolak R, Hines M, Cronenwett JL. The durability of endovascular treatment of multisegment iliac occlusive disease. J Vasc Surg. 2000;31:1178–84.
11.
Saket RR, Razavi MK, Padidar A, Kee ST, Sze DY, Dake MD. Novel intravascular ultrasound-guided method to create transintimal arterial communications: initial experience in peripheral occlusive disease and aortic dissection. J Endovasc Ther. 2004;11:274–80.CrossRefPubMed
12.
Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O’Hara PJ, Lyden SP, Clair DG. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg. 2008;48:1451–7.
13.
Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Röther J, Sievert H, van Sambeek M, Zeller T. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology. Eur Heart J. 2011;32:2851–906.
14.
Ichihashi S, Higashiura W, Itoh H, Sakaguchi S, Nishimine K, Kichikawa K. Long-term outcomes for systematic primary stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-Society Consensus (TASC)-II. J Vasc Surg. 2011;53:992–9.CrossRefPubMed
15.
Schillinger M, Minar E. Endovascular stent implantation for treatment of peripheral artery disease. Eur J Clin Invest. 2007;37:165–70.CrossRefPubMed
16.
Hassen-Khodja R, Sala F, Declemy S, Bouillanne PJ, Batt M, Staccini P. Value of stent placement during percutaneous transluminal angioplasty of the iliac arteries. J Cardiovasc Surg. 2001;42:369–74.
17.
Murphy TP, Webb MS, Lambiase RE, Haas RA, Dorfman GS, Carney Jr WI, Morin CJ. Percutaneous revascularization of complex iliac artery stenoses and occlusions with use of Wallstents: three-year experience. J Vasc Interv Radiol. 1996;7:21–7.
18.
Stoeckel D, Pelton A, Duerig T. Self-expanding nitinol stents: material and design considerations. Eur Radiol. 2004;14:292–301.CrossRefPubMed
19.
Dyet JF, Watts WG, Ettles DF, Nicholson AA. Mechanical properties of metallic stents: how do these properties influence the choice of stent for specific lesions? Cardiovasc Intervent Radiol. 2000;23:47–54.CrossRefPubMed
20.
Duda SH, Wiskirchen J, Tepe G, Bitzer M, Kaulich TW, Stoeckel D, Claussen CD. Physical properties of endovascular stents: an experimental comparison. J Vasc Interv Radiol. 2000;11:645–54.
21.
Henry M, Klonaris C, Amor M, Henry I, Tzvetanov K. State of the art: which stent for which lesion in peripheral interventions? Tex Heart Inst J. 2000;27:119–26.PubMedPubMedCentral
22.
Ponec D, Jaff MR, Swischuk J, Feiring A, Laird J, Mehra M, Popma JJ, Donohoe D, Firth B, Keim E, Snead D; CRISP Study Investigators. The Nitinol SMART stent vs Wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results. J Vasc Interv Radiol. 2004;15:911–8.
23.
Stockx L, Poncyljusz W, Krzanowski M, Schroë H, Allocco DJ, Dawkins KD, MELODIE Investigators. Express LD vascular stent in the treatment of iliac artery lesions: 24-month results from the MELODIE trial. J Endovasc Ther. 2010;17:633–41.
24.
Grenacher L, Rohde S, Gänger E, Deutsch J, Kauffmann GW, Richter GM. In vitro comparison of self-expanding versus balloon-expandable stents in a human ex vivo model. Cardiovasc Intervent Radiol. 2006;29:249–54.CrossRefPubMed
25.
Molnar RG, Gray WA, ACTIVE Trial Investigators. Sustained patency and clinical improvement following treatment of atherosclerotic iliac artery disease using the Assurant cobalt iliac balloon-expandable stent system. J Endovasc Ther. 2013;20:94–103.CrossRefPubMed
26.
Reekers JA, Vorwerk D, Rousseau H, Sapoval MR, Gaines PA, Stockx L, Delcour CP, Raat H, Voshage G, Biamino G, Hoogeveen YL. Results of a European multicentre iliac stent trial with a flexible balloon expandable stent. Eur J Vasc Endovasc Surg. 2002;24:511–5.
27.
Marrey RV, Burgermeister R, Grishaber RB, Ritchie RO. Fatigue and life prediction for cobalt-chromium stents: a fracture mechanics analysis. Biomaterials. 2006;27:1988–2000.CrossRefPubMed
28.
Scheinert D, Scheinert S, Sax J, Piorkowski C, Bräunlich S, Ulrich M, Biamino G, Schmidt A. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–5.
29.
Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517–38.
30.
Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, Diehm C, Biamino G, Vermassen F, Scheinert D, van Sambeek MR, Schillinger M. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J. 2007;28:798–805.
Metadata
Title
Study design and rationale of the ‘Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial’: study protocol for a randomized controlled trial
Authors
Woong Gil Choi
Seung Woon Rha
Cheol Ung Choi
Eung Ju Kim
Dong Joo Oh
Yoon Hyung Cho
Sang Ho Park
Seung Jin Lee
Ae Yong Hur
Young Guk Ko
Sang Min Park
Ki Chang Kim
Joo Han Kim
Min Woong Kim
Sang Min Kim
Jang Ho Bae
Jung Min Bong
Won Yu Kang
Jae Bin Seo
Woo Yong Jung
Jang Hyun Cho
Do Hoi Kim
Ji Hoon Ahn
Soo Hyun Kim
Ji Yong Jang
SENS-ILIAC Investigators
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1435-9

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