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Клиническое исследование

Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions

NCT: NCT05417893 · WITHDRAWN

NCT IDNCT05417893
СтатусWITHDRAWN
Дата начала2022-10-15
Завершение2023-09-23

Краткое описание

This is a prospective, open-label, multicentre, randomized, non-inferiority clinical trial to compare the safety and performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System versus Contemporary drug-eluting stent platforms in patients with de novo coronary artery lesions at 60 investigational sites globally (including India). The primary objective of this study is to evaluate safety and performance of MeRes100 BRS in comparison with XIENCE family EES/Resolute ZES/Synergy EES/BioMime/Metafor/Proficient family SES in patients with de novo coronary artery lesions with reference vessel diameter of ≥2.75 mm to ≤4.0 mm and lesion length ≤34 mm. Subject's Clinical/Telephonic Follow-up will be taken at \[Time Frame: 30 days (± 7 days) clinical follow-up, 6 month (± 28 days) clinical follow-up, 1 year (± 28 days) clinical follow-up, 2 years (± 28 days) telephonic follow-up, 3 years (± 28 days) clinical follow-up, 4 years (± 28 days) telephonic follow-up and 5 years (± 28 days) clinical follow-up\]

Официальный источник

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Данные получены через API ClinicalTrials.gov. Актуальный статус смотрите в официальной записи.

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