title: Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Registered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT01570803).
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Park
authors.affiliation: Cardiovascular Center, Korea University Guro Hospital, 80 Guro-dong, Guro-gu, Seoul 152-703, Republic of Korea. swrha617@yahoo.co.kr.
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Rha
authors.forename: Cheol Ung
authors.initials: CU
authors.lastname: Choi
authors.forename: Eung Ju
authors.initials: EJ
authors.lastname: Kim
authors.forename: Dong Joo
authors.initials: DJ
authors.lastname: Oh
authors.forename: Yun Hyeong
authors.initials: YH
authors.lastname: Cho
authors.forename: Woong Gil
authors.initials: WG
authors.lastname: Choi
authors.forename: Seung Jin
authors.initials: SJ
authors.lastname: Lee
authors.forename: Yong Hoon
authors.initials: YH
authors.lastname: Kim
authors.forename: Seung Hyuk
authors.initials: SH
authors.lastname: Choi
authors.forename: Won Ho
authors.initials: WH
authors.lastname: Kim
authors.forename: Ki Chang
authors.initials: KC
authors.lastname: Kim
authors.forename: Jang Hyun
authors.initials: JH
authors.lastname: Cho
authors.forename: Joo Han
authors.initials: JH
authors.lastname: Kim
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Kim
authors.forename: Jang Ho
authors.initials: JH
authors.lastname: Bae
authors.forename: Jung Min
authors.initials: JM
authors.lastname: Bong
authors.forename: Won Yu
authors.initials: WY
authors.lastname: Kang
authors.forename: Ju Yeol
authors.initials: JY
authors.lastname: Baek
authors.forename: Jae Bin
authors.initials: JB
authors.lastname: Seo
authors.forename: Woo Young
authors.initials: WY
authors.lastname: Chung
authors.forename: Mahn Won
authors.initials: MW
authors.lastname: Park
authors.forename: Sung Ho
authors.initials: SH
authors.lastname: Her
authors.forename: Jon
authors.initials: J
authors.lastname: Suh
authors.forename: Min Woong
authors.initials: MW
authors.lastname: Kim
authors.forename: Yeo Joo
authors.initials: YJ
authors.lastname: Kim
authors.forename: Hwan Jun
authors.initials: HJ
authors.lastname: Choi
authors.forename: Jae Wan
authors.initials: JW
authors.lastname: Soh
mesh_terms: D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001241:Aspirin / Q000627:therapeutic use; D000077407:Cilostazol; D002985:Clinical Protocols; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012107:Research Design; D015607:Stents; D013777:Tetrazoles / Q000627:therapeutic use; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; C013616:nitinol; D000077144:Clopidogrel; D000077407:Cilostazol; D013988:Ticlopidine; D001241:Aspirin