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Clinical Trial Summary

The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.


Clinical Trial Description

Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03809715
Study type Observational
Source B. Braun Melsungen AG
Contact
Status Active, not recruiting
Phase
Start date January 17, 2019
Completion date June 2025

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