Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease SENS-FP trial: study protocol for a randomized controlled trialReport as inadecuate




Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease SENS-FP trial: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:355

First Online: 10 September 2014Received: 01 March 2014Accepted: 20 August 2014DOI: 10.1186-1745-6215-15-355

Cite this article as: Park, S.H., Rha, S.W., Choi, C.U. et al. Trials 2014 15: 355. doi:10.1186-1745-6215-15-355

Abstract

BackgroundThere have been few randomized control trials comparing the incidence of stent fracture and primary patency among different self-expanding nitinol stents to date. The SMART™ CONTROL stent Cordis Corp, Miami Lakes, Florida, United States has a peak-to-valley bridge and inline interconnection, whereas the COMPLETE™-SE stent Medtronic Vascular, Santa Rosa, California, United States crowns have been configured to minimize crown-to-crown interaction, increasing the stent-s flexibility without compromising radial strength. Further, the 2011 ESC European society of cardiology guidelines recommend that dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel should be administered for at least one month after infrainguinal bare metal stent implantation. Cilostazol has been reported to reduce intimal hyperplasia and subsequent repeat revascularization. To date, there has been no randomized study comparing the safety and efficacy of two different antiplatelet regimens, clopidogrel and cilostazol, following successful femoropopliteal stenting.

Methods-DesignThe primary purpose of our study is to examine the incidence of stent fracture and primary patency between two different major representative self-expanding nitinol stents SMART™ CONTROL versus COMPLETE™-SE in stenotic or occlusive femoropopliteal arterial lesion. The secondary purpose is to examine whether there is any difference in efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol for one month following stent implantation in femoropopliteal lesions. This is a prospective, randomized, multicenter trial to assess the efficacy of the COMPLETE™-SE versus SMART™ CONTROL stent for provisional stenting after balloon angioplasty in femoropopliteal arterial lesions. The study design is a 2x2 randomization design and a total of 346 patients will be enrolled. The primary endpoint of this study is the rate of binary restenosis in the treated segment at 12 months after intervention as determined by catheter angiography or duplex ultrasound.

DiscussionThis trial will provide powerful insight into whether the design of the COMPLETE™-SE stent is more fracture-resistant or effective in preventing restenosis compared with the SMART™ CONTROL stent. Also, it will determine the efficacy and safety of aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions.

Trial registrationRegistered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry ClinicalTrials.gov identifier# NCT01570803.

AbbreviationsCTOChronic total occlusion

ECSEuropean Society of Cardiology

U.S. FDAUnited State Food and Drug Administration

PADPeripheral arterial disease

PCIPercutaneous coronary intervention

PSVRPeak systolic velocity ratio

SFAsuperficial femoral artery

TASCTransatlantic Inter-Society Consensus.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-355 contains supplementary material, which is available to authorized users.

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Author: Sang Ho Park - Seung Woon Rha - Cheol Ung Choi - Eung Ju Kim - Dong Joo Oh - Yun Hyeong Cho - Woong Gil Choi - Seung

Source: https://link.springer.com/







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