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Clinical Trial Summary

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


Clinical Trial Description

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Angiolite 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 NCT05292014
Study type Observational
Source Fundación EPIC
Contact FUNDACION EPIC
Phone 987225638
Email iepic@fundacionepic.org
Status Recruiting
Phase
Start date September 26, 2022
Completion date March 30, 2025

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