Essential Pro Study ( rEPIC04E-HK )

Fundación EPIC

Status

Enrolling

Conditions

Ischemic Heart Disease

Coronary Artery Disease

Treatments

Device: Essential pro

Study type

Observational

Funder types

Other

Identifiers

NCT06631157

rEPIC04E-HK- Pro Study-HK

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria