Safety and efficacy of drug-eluting stents versus heparin-bonded stents in treatment of femoropopliteal peripheral artery disease: study protocol for a multicentre, prospective randomised controlled trial in China (ELITE trial).
BMJ Open
; 14(8): e080560, 2024 Aug 07.
Article
in En
| MEDLINE
| ID: mdl-39117410
ABSTRACT
INTRODUCTION:
Endovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered stents have exhibited enhanced clinical outcomes compared with bare metal stents. However, there is currently a lack of level I evidence comparing the safety and efficacy of paclitaxel-eluting stents and heparin-bonded covered stents. Therefore, the primary objective of this study is to systematically evaluate the efficacy and safety outcomes of these two types of stents. METHODS ANDANALYSIS:
The ELITE trial is a prospective, multicentre, parallel, randomised controlled trial. A total of 450 patients will be recruited. The primary endpoints of the study include primary patency at 1 year post-index procedure. ETHICS AND DISSEMINATION Ethical approval for this study was obtained from the Ethics Committee of West China Hospital of Sichuan University (approval number 2023-1186). The results will be submitted to a major clinical journal for peer review and publication. TRIAL REGISTRATION ELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Popliteal Artery
/
Heparin
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Drug-Eluting Stents
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Femoral Artery
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Peripheral Arterial Disease
Limits:
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
En
Journal:
BMJ Open
Year:
2024
Document type:
Article
Affiliation country: