Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial

Autor:	Aljoscha Rastan, Tanja Böhme, Thomas Zeller
Jazyk:	angličtina
Rok vydání:	2024
Předmět:	Common femoral artery Surgery Atherectomy Drug-coated balloon Angioplasty Peripheral artery disease Medicine (General) R5-920
Zdroj:	Trials, Vol 25, Iss 1, Pp 1-11 (2024)
Druh dokumentu:	article
ISSN:	1745-6215
DOI:	10.1186/s13063-024-08219-1
Popis:	Abstract Background Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. Methods This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis
Databáze:	Directory of Open Access Journals
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