Abstract
BackgroundThe 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/designThe 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.DiscussionThe 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 registrationNational Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495), registration date: May 8, 2012Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1435-9) contains supplementary material, which is available to authorized users.
Highlights
The self-expandable COMPLETETM stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBATM stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions
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
In a meta-analysis of iliac artery intervention studies, the risk of long-term failure was reduced by 39 % after stent placement compared with percutaneous transluminal angioplasty (PTA) and the technical success rate was higher after stent placement [7]
Summary
The self-expandable COMPLETETM stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBATM stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. In endovascular repair for iliac lesions, unlike the infrapopliteal revascularization strategy, routine stent placement with a PTA strategy has been generally accepted [15] It was seen in a study of 250 patients undergoing either PTA alone or PTA with provisional stenting that the provisional stenting arm was associated with more than a 2.5-fold reduction (10 vs 4 %) in immediate failures, long-term results in the two groups were similar [16]. A study comparing angioplasty alone with angioplasty plus stenting for complex iliac artery disease showed that cumulative primary patency rates were 78 % at 1 year, with a secondary patency rate more than 80 % at 32 months, with reduction in longterm failure of 39 % when stents were used [17] In this analysis, stenting improved the 4-year primary patency rates by approximately 10 % for both patients treated for claudication or critical ischemia, and patients treated for iliac stenosis and occlusions
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