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

Sang Ho Park, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yun Hyeong Cho, Woong Gil Choi, Seung Jin Lee, Yong Hoon Kim, Seung Hyuk Choi, Won Ho Kim, Ki Chang Kim, Jang Hyun Cho, Joo Han Kim, Sang Min Kim, Jang Ho Bae, Jung Min Bong, Won Yu Kang, Ju Yeol Baek, Jae Bin Seo, Woo Young Chung, Mahn Won Park, Sung Ho Her, Jon Suh, Min Woong Kim, Yeo Joo Kim, Hwan Jun Choi, Jae Wan Soh, SENS-FP Investigators, Sang Ho Park, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yun Hyeong Cho, Woong Gil Choi, Seung Jin Lee, Yong Hoon Kim, Seung Hyuk Choi, Won Ho Kim, Ki Chang Kim, Jang Hyun Cho, Joo Han Kim, Sang Min Kim, Jang Ho Bae, Jung Min Bong, Won Yu Kang, Ju Yeol Baek, Jae Bin Seo, Woo Young Chung, Mahn Won Park, Sung Ho Her, Jon Suh, Min Woong Kim, Yeo Joo Kim, Hwan Jun Choi, Jae Wan Soh, SENS-FP Investigators

Abstract

Background: There 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/design: The 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.

Discussion: This 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 registration: Registered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT01570803).

Figures

Figure 1
Figure 1
Flow chart of the enrolled patients. ABI: Ankle-brachial index; PCI: Percutaneous coronary intervention.
Figure 2
Figure 2
Comparison for stent design. A; Complete-SE stent design, B; SMART™ CONTROL stent design. Complete-SE stent is different to SMART™ CONTROL stent in that the configuration of interconnection of Complete-SE has peak-to-peak connection, fewer bridges (4 versus 6) and struts (24 versus 36), a larger cell size, and a more spiral orientation of interconnection, compared to the SMART™ CONTROL stent. On the other hand, the SMART™ CONTROL stent has the peak-to-valley bridge, more bridges, a smaller cell size, and inline interconnection.

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