title: Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.
abstract: The 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.
  
  
  
  The 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.
  
  
  
  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.
  
  
  
  National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.
authors.affiliation: Department of Internal Medicine, School of Medicine, Konkuk University, Chungju, Korea.
authors.forename: Woong Gil
authors.initials: WG
authors.lastname: Choi
authors.affiliation: Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea. swrha617@yahoo.co.kr.
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Rha
authors.affiliation: Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea.
authors.forename: Cheol Ung
authors.initials: CU
authors.lastname: Choi
authors.affiliation: Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea.
authors.forename: Eung Ju
authors.initials: EJ
authors.lastname: Kim
authors.affiliation: Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea.
authors.forename: Dong Joo
authors.initials: DJ
authors.lastname: Oh
authors.affiliation: Cardiovascular Center, Myong-Ji General Hospital, Ilsan, Korea.
authors.forename: Yoon Hyung
authors.initials: YH
authors.lastname: Cho
authors.affiliation: Department of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Park
authors.affiliation: Department of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Seung Jin
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Cardiovascular Center, Kangwon University, Chuncheon, Korea.
authors.forename: Ae Yong
authors.initials: AY
authors.lastname: Hur
authors.affiliation: Cardiovascular Center, Severance Hospital, Seoul, Korea.
authors.forename: Young Guk
authors.initials: YG
authors.lastname: Ko
authors.affiliation: Department of Cardiology, Chuncheon Sacred Heart Hospital, Chuncheon, Korea.
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Park
authors.affiliation: Cardiovascular Center, Incheon Sa-Rang General Hospital, Incheon, Korea.
authors.forename: Ki Chang
authors.initials: KC
authors.lastname: Kim
authors.affiliation: Cardiovascular Center, Chunnam University Hospital, Kwangu, Korea.
authors.forename: Joo Han
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Hanyang University Medical Center Hanmaeum Hospital, Changwon, Korea.
authors.forename: Min Woong
authors.initials: MW
authors.lastname: Kim
authors.affiliation: Cardiovascular Center, Chungbuk University, Cheongju, Korea.
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Kim
authors.affiliation: Cardiovascular Center, Konyang University Hospital, Daejon, Korea.
authors.forename: Jang Ho
authors.initials: JH
authors.lastname: Bae
authors.affiliation: Cardiovascular Center, Incheon, Hanlim General Hospital, Incheon, Korea.
authors.forename: Jung Min
authors.initials: JM
authors.lastname: Bong
authors.affiliation: Cardiovascular Center, Kwanju Veterans General Hospital, Kwangju, Korea.
authors.forename: Won Yu
authors.initials: WY
authors.lastname: Kang
authors.affiliation: Cardiovascular Center, Seoul University Boraemea Hospital, Seoul, Korea.
authors.forename: Jae Bin
authors.initials: JB
authors.lastname: Seo
authors.affiliation: Cardiovascular Center, Seoul University Boraemea Hospital, Seoul, Korea.
authors.forename: Woo Yong
authors.initials: WY
authors.lastname: Jung
authors.affiliation: Department of Cardiology, St. Carollo Hospital, Suncheon, Korea.
authors.forename: Jang Hyun
authors.initials: JH
authors.lastname: Cho
authors.affiliation: Cardiovascular Center, Soonchunhyang University Gumi Hospital, Gumi, Korea.
authors.forename: Do Hoi
authors.initials: do H
authors.lastname: Kim
authors.affiliation: Cardiovascular Center, Soonchunhyang University Gumi Hospital, Gumi, Korea.
authors.forename: Ji Hoon
authors.initials: JH
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, School of Medicine, Konkuk University, Chungju, Korea.
authors.forename: Soo Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, School of Medicine, Konkuk University, Chungju, Korea.
authors.forename: Ji Yong
authors.initials: JY
authors.lastname: Jang
mesh_terms: D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002858:Chromium Alloys; D002985:Clinical Protocols; D003251:Constriction, Pathologic; D004548:Elasticity; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D056910:Republic of Korea; D012107:Research Design; D000069322:Self Expandable Metallic Stents; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D002858:Chromium Alloys; C013616:nitinol