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Search / Trial NCT05292092

Essential Pro PMCF Study ( rEPIC04E )

Launched by FUNDACIÓN EPIC · Mar 14, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Mdr (Medical Device Regulations) Pmcf (Post Market Clinical Follow Up) Paclitaxel Eluting Coronary Balloon Dilatation Catheter

ClinConnect Summary

The Essential Pro PMCF Study (rEPIC04E) is a clinical trial aimed at understanding how safe and effective the Essential Pro device is for patients with coronary artery disease (CAD) and ischemic heart disease. This study is important because it helps ensure that the device meets European safety regulations. The trial is currently recruiting participants, and it is open to individuals aged 65 to 74 who have been treated with the Essential Pro device in their hospital. To join the study, participants need to provide their signed consent, confirming they understand what the trial involves.

If you decide to participate, you can expect to be part of a multicenter study, meaning it will take place across several hospitals. Since this is a post-market follow-up study, it will focus on collecting information about the device's performance and safety in patients who have already received it as part of their regular treatment. Your experiences will help researchers and medical professionals ensure the device continues to meet high safety standards for future patients.

Gender

ALL

Eligibility 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

About Fundación Epic

Fundación Epic is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a robust focus on improving patient outcomes, the foundation collaborates with healthcare professionals, research institutions, and industry partners to design and implement clinical studies across various therapeutic areas. Fundación Epic emphasizes ethical standards, scientific integrity, and patient safety, ensuring that all trials are conducted with the utmost care and rigor. Through its commitment to fostering cutting-edge research and promoting collaboration, Fundación Epic aims to contribute significantly to the development of new therapies and improve healthcare solutions globally.

Locations

Barcelona, , Spain

Santander, , Spain

Málaga, , Spain

Jerez De La Frontera, , Spain

León, , Spain

Algeciras, , Spain

Puerto Real, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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