Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial)

Study protocol for a randomized controlled trial

SENS-FP Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Article number355
JournalTrials
Volume15
Issue number1
DOIs
Publication statusPublished - 2014 Sep 10

Fingerprint

Stents
Randomized Controlled Trials
clopidogrel
Crowns
Aspirin
nitinol
Tunica Intima
Safety
Balloon Angioplasty
Incidence
Lakes
Random Allocation
Cardiology
Multicenter Studies
Hyperplasia
Blood Vessels
Angiography
Catheters
Metals
Guidelines

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{83ce41d5cede49c2bfe5590dc730ebd4,
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/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.",
author = "{SENS-FP Investigators} and Park, {Sang H.} and Seung-Woon Rha and Choi, {Cheol Ung} and Kim, {Eung Ju} and Oh, {Dong J.} and Cho, {Yun H.} and Choi, {Woong G.} and Lee, {Seung J.} and Kim, {Yong H.} and Choi, {Seung H.} and Kim, {Won H.} and Kim, {Ki C.} and Cho, {Jang H.} and Kim, {Joo H.} and Kim, {Sang M.} and Bae, {Jang H.} and Bong, {Jung M.} and Kang, {Won Y.} and Baek, {Ju Y.} and Seo, {Jae B.} and Chung, {Woo Y.} and Park, {Mahn W.} and Her, {Sung H.} and Jon Suh and Kim, {Min W.} and Kim, {Yeo J.} and Choi, {Hwan J.} and Soh, {Jae W.}",
year = "2014",
month = "9",
day = "10",
doi = "10.1186/1745-6215-15-355",
language = "English",
volume = "15",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial)

T2 - Study protocol for a randomized controlled trial

AU - SENS-FP Investigators

AU - Park, Sang H.

AU - Rha, Seung-Woon

AU - Choi, Cheol Ung

AU - Kim, Eung Ju

AU - Oh, Dong J.

AU - Cho, Yun H.

AU - Choi, Woong G.

AU - Lee, Seung J.

AU - Kim, Yong H.

AU - Choi, Seung H.

AU - Kim, Won H.

AU - Kim, Ki C.

AU - Cho, Jang H.

AU - Kim, Joo H.

AU - Kim, Sang M.

AU - Bae, Jang H.

AU - Bong, Jung M.

AU - Kang, Won Y.

AU - Baek, Ju Y.

AU - Seo, Jae B.

AU - Chung, Woo Y.

AU - Park, Mahn W.

AU - Her, Sung H.

AU - Suh, Jon

AU - Kim, Min W.

AU - Kim, Yeo J.

AU - Choi, Hwan J.

AU - Soh, Jae W.

PY - 2014/9/10

Y1 - 2014/9/10

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84908102457&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908102457&partnerID=8YFLogxK

U2 - 10.1186/1745-6215-15-355

DO - 10.1186/1745-6215-15-355

M3 - Article

VL - 15

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 355

ER -