Essential Pro Study ( rEPIC04E-HK )

NCT ID: NCT06631157

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease (CAD)

Essential pro

Intervention Type DEVICE

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

Interventions

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Essential pro

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient treated with Essential Pro according to routine hospital practice and following instructions for use
* Informed consent signed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Princess Margaret Hospital

Lai Chi Kok, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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FUNDACION EPIC

Role: CONTACT

0034987225638

References

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Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.

Reference Type BACKGROUND
PMID: 74678 (View on PubMed)

Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021.

Reference Type BACKGROUND
PMID: 33953973 (View on PubMed)

Other Identifiers

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rEPIC04E-HK- Pro Study-HK

Identifier Type: -

Identifier Source: org_study_id

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