Status:

COMPLETED

ANGIOLITE PMCF Study ( rEPIC04F )

Lead Sponsor:

Fundación EPIC

Conditions:

Coronary Artery Disease (CAD)

Ischemic Heart Disease

Eligibility:

All Genders

18+ years

Brief 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...

Detailed 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 Elu...

Eligibility Criteria

Inclusion

  • Patients treated with ANGIOLITE according to routine hospital practice and following instructions for use
  • Informed consent signed

Exclusion

  • • Not meet inclusion criteria

Key Trial Info

Start Date :

September 26 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 3 2024

Estimated Enrollment :

81 Patients enrolled

Trial Details

Trial ID

NCT05292014

Start Date

September 26 2022

End Date

August 3 2024

Last Update

June 15 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

2

H. Puerta Del Mar

Cadiz, Spain, 11009

3

Hospital Universitario de Leon

León, Spain, 24080

4

Hospital Universitario Virgen de La Victoria

Málaga, Spain, 29010

ANGIOLITE PMCF Study ( rEPIC04F ) | DecenTrialz