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

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

Trials, September 2014

25208688

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

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.