Xperience Pro PMCF Study (rEPIC04A)

Fundación EPIC

Status: Completed

Conditions: Ischemic Heart Disease; Coronary Artery Disease (CAD)

Treatments: Device: Xperience Pro

Study type: Observational

Funder types: Other

Identifiers

NCT05292144

Xperience Pro PMCF Study

Details and patient eligibility

About

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .

Full description

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Xperience Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient treated with Xperience pro according to routine hospital practice and following instructions for use
• Informed consent signed

Exclusion criteria

• Not meet inclusion criteria

Trial design

46 participants in 1 patient group

Coronary Artery Disease (CAD)

Treatment:

Device: Xperience Pro