Essential Pro Study ( rEPIC04E-HK ) (rEPIC04E-HK)

February 12, 2026 updated by: Fundación EPIC

Essential Pro Post-Market Clinical Follow-up Study

Single center, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study intends to analyze:

  • Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used).
  • Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used).
  • Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Lai Chi Kok, Hong Kong
        • Recruiting
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with Essential Pro according to routine hospital practice and following instructions for use

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease (CAD)
Device: Essential pro
Patients in whom treatment with (Essential Pro) has been attempted

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rEPIC04E-HK- Pro Study-HK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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