Essential Pro PMCF Study ( rEPIC04E )

Last updated: January 19, 2026
Sponsor: Fundación EPIC
Overall Status: Completed

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Hypercholesterolemia

Coronary Artery Disease

Treatment

Essential pro

Clinical Study ID

NCT05292092
Essential Pro PMCF Study
  • Ages > 18
  • All Genders

Study 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 (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient treated with Essential Pro according to routine hospital practice andfollowing instructions for use

  • Informed consent signed

Exclusion

Exclusion Criteria:

• Not meet inclusion criteria

Study Design

Total Participants: 161
Treatment Group(s): 1
Primary Treatment: Essential pro
Phase:
Study Start date:
September 26, 2022
Estimated Completion Date:
January 18, 2026

Study 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-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.

Connect with a study center

  • Hospital Punta de Europa

    Algeciras, 11207
    Spain

    Site Not Available

  • Hospital Punta de Europa

    Algeciras 2522013, 11207
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez De La Frontera, 11407
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera 2516326, 11407
    Spain

    Site Not Available

  • Hospital Universitario de Leon

    León, 24080
    Spain

    Site Not Available

  • Hospital Universitario de Leon

    León 3118532, 24080
    Spain

    Site Not Available

  • Hospital Universitario Regional de Malaga

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Regional de Malaga

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Puerto Real, 11510
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Puerto Real 2512169, 11510
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander 3109718, 39008
    Spain

    Site Not Available

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