Essential Pro paclitaxel‑eluting coronary balloon post-market follow-up (rEPIC04E-HK)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Princess Margaret Hospital
  Lai Chi Kok, Hong Kong Recruiting

Study contacts

• Study coordinator: Fundacion Epic
• Email: iepic@fundacionepic.org
• Phone: 0034987225638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.