Essential Pro PMCF Study ( rEPIC04E )

N/ACompletedNCT05292092

Fundación EPIC161 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

161

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Interventions

Essential proDRUG

Patients in whom treatment with (Essential Pro) has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Hospital Punta de Europa

Algeciras, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Spain

Hospital Universitario de Leon

León, Spain

Outcomes

Primary Outcomes

Safety Endpoint. Freedom from Target Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).

Time frame: 12 months

Secondary Outcomes

Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Time frame: 12 months

Freedom from Balloon rupture

Time frame: During percutaneous coronary intervention (PCI)

Freedom from Hypotube rupture

Time frame: During PCI

Freedom from Complicated withdrawal

Time frame: During PCI

Freedom from Coronary perforation

Time frame: During PCI

Freedom from Coronary dissection >C

Freedom from Coronary dissection \>C

Time frame: During PCI

Freedom from No reflow

Time frame: During PCI

Data from ClinicalTrials.gov

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