Status:

RECRUITING

Essential Pro PMCF Study ( rEPIC04E )

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 Essential Pro to meet EU Medical Device regulation (...

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 Essential Pro in a NON-...

Eligibility Criteria

Inclusion

  • Patient treated with Essential Pro 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 :

ESTIMATED

End Date :

August 30 2025

Estimated Enrollment :

176 Patients enrolled

Trial Details

Trial ID

NCT05292092

Start Date

September 26 2022

End Date

August 30 2025

Last Update

June 24 2025

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Hospital Punta de Europa

Algeciras, Spain, 11207

2

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

3

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Spain, 11407

4

Hospital Universitario de Leon

León, Spain, 24080