NCT06631157

Essential Pro Study ( rEPIC04E-HK )

Essential Pro Post-Market Clinical Follow-up Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Coronary Artery Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Essential pro	Patients in whom treatment with (Essential Pro) has been attempted

Timeline

• Start date: 2025-05-15
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-10-08
• Last updated: 2026-02-17

Locations

1 site across 1 country: Hong Kong