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Essential Pro PMCF Study ( rEPIC04E )

Essential Pro PMCF Study ( rEPIC04E )

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Patient treated with Essential Pro according to routine hospital practice and following instructions for use
  • Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria

Study details
    Coronary Artery Disease (CAD)
    Ischemic Heart Disease

NCT05292092

Fundación EPIC

16 February 2024

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