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Clinical Trial Summary

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.


Clinical Trial Description

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05698732
Study type Observational
Source Fundación EPIC
Contact koldobika García San Román, MD, PhD
Phone 0034696704643
Email koldobikags@hotmail.com
Status Recruiting
Phase
Start date August 4, 2023
Completion date February 1, 2027

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