Essential Pro paclitaxel‑eluting coronary balloon post-market follow-up (rEPIC04E-HK)
Essential Pro Post-Market Clinical Follow-up Study
This project will follow people with coronary artery disease treated with the Essential Pro paclitaxel‑eluting coronary balloon to see if the device is safe and works well in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 1 site (Lai Chi Kok) |
| Trial ID | NCT06631157 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective, non-randomized post-market clinical follow-up enrolling all consecutive patients treated with the Essential Pro device according to routine hospital practice and the device instructions for use. The protocol captures device and procedural technical performance and safety at the end of the lesion treatment and during a follow-up period defined by the relevant Notified Body. Collected outcomes include device effectiveness, procedural success, and device- or procedure-related adverse events. Data are intended to support compliance with EU Medical Device Regulation (MDR) post-market clinical follow-up requirements.
Who should consider this trial
Good fit: Adults with coronary artery disease who are treated with the Essential Pro paclitaxel‑eluting coronary balloon and can provide informed consent are eligible.
Not a fit: Patients not treated with the Essential Pro device or those unable to give informed consent will not benefit from participation.
Why it matters
Potential benefit: If successful, the results could reassure patients and clinicians that the Essential Pro device performs reliably and has an acceptable safety profile in real-world use.
How similar studies have performed: Post-market follow-up of paclitaxel‑eluting coronary devices has been done previously with mixed results, so this registry adds real-world safety and performance data to an existing but not definitive literature base.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lai Chi Kok
- Princess Margaret Hospital — Lai Chi Kok, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Fundacion Epic
- Email: iepic@fundacionepic.org
- Phone: 0034987225638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.