Xperience Pro PMCF Study

Completed

• Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease
• Interventions: Device: Xperience Pro

• Registration Number: NCT05292144
• Lead Sponsor: Fundación EPIC

Brief Summary

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 .

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Study Start: 2022-10-26
• Primary Completion: 2023-04-26
• Status Verified: 2023-05
• Study Completion: 2023-05-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Xperience Pro	-

Primary Outcome Measures

Name	Time	Method
Safety Endpoint. Freedom from Target Lesion Failure	7 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction and and new Target Lesion Revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint. Freedom from Target Lesion Failure	7 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and and new Target Lesion Revascularization (TLR).
Freedom from Hypotube rupture	During PCI	Freedom from Hypotube rupture
Freedom from Coronary thrombosis	During PCI	Freedom from Coronary thrombosis
Freedom from Coronary perforation	During PCI	Freedom from Coronary perforation
Freedom from Coronary dissection >C	During PCI	Freedom from Coronary dissection \>C
Freedom from No reflow	During PCI	Freedom from No reflow
Freedom from Balloon rupture	During percutaneous coronary intervention (PCI)	Freedom from Balloon rupture
Freedom from Complicated withdrawal	During PCI	Freedom from Complicated withdrawal

Trial Locations

Locations (5)

Hospital Universitario de Getafe; 🇪🇸 Getafe, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain