Essential Pro PMCF Study ( rEPIC04E )

Recruiting

• Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease
• Interventions: Drug: Essential pro

• Registration Number: NCT05292092
• Lead Sponsor: Fundación EPIC

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

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-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 Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Study Start: 2022-09-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-02-02
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Essential pro	-

Primary Outcome Measures

Name	Time	Method
Safety Endpoint. Freedom from Target Lesion Failure	12 months	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).

Secondary Outcome Measures

Name	Time	Method
Freedom from Hypotube rupture	During PCI	Freedom from Hypotube rupture
Freedom from Coronary perforation	During PCI	Freedom from Coronary perforation
Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)	12 months	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Freedom from No reflow	During PCI	Freedom from No reflow
Freedom from Balloon rupture	During percutaneous coronary intervention (PCI)	Freedom from Balloon rupture
Freedom from Complicated withdrawal	During PCI	Freedom from Complicated withdrawal
Freedom from Coronary dissection >C	During PCI	Freedom from Coronary dissection \>C
Freedom from Coronary thrombosis	During PCI	Freedom from Coronary thrombosis

Trial Locations

Locations (7)

Hospital Universitario de Jerez de la Frontera; 🇪🇸 Jerez De La Frontera, Spain

Hospital Universitario de Leon; 🇪🇸 León, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Punta de Europa; 🇪🇸 Algeciras, Spain

Hospital Universitario Regional de Malaga; 🇪🇸 Málaga, Spain

Hospital Universitario de Puerto Real; 🇪🇸 Puerto Real, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain