Essential Pro Study ( rEPIC04E-HK )
rEPIC04E-HK
Essential Pro Post-Market Clinical Follow-up Study
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 17, 2026
February 1, 2026
1.5 years
October 2, 2024
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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). Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).
12 months
Secondary Outcomes (8)
Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)
12 months
Freedom from Balloon rupture
During PCI
Freedom from Hypotube rupture
During PCI
Freedom from Complicated withdrawal
During PCI
Freedom from Coronary perforation
During PCI
- +3 more secondary outcomes
Study Arms (1)
Coronary Artery Disease (CAD)
Interventions
Patients in whom treatment with (Essential Pro) has been attempted
Eligibility Criteria
Patients treated with Essential Pro according to routine hospital practice and following instructions for use
You may qualify if:
- Patient treated with Essential Pro according to routine hospital practice and following instructions for use
- Informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
Study Sites (1)
Princess Margaret Hospital
Lai Chi Kok, Hong Kong
Related Publications (2)
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.
PMID: 74678BACKGROUNDWu 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.
PMID: 33953973BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2024
First Posted
October 8, 2024
Study Start
May 15, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02