Xperience Pro PMCF Study (rEPIC04A)

May 26, 2023 updated by: Fundación EPIC

Xperience Pro Post-Market Clinical Follow-up Study

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Getafe, Spain, 28905
        • Hospital Universitario de Getafe
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Sevilla, Spain, 41014
        • Hospital Universitario Virgen de Valme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with Xperience pro according to routine hospital practice and following instructions for use

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease (CAD)
Device: Xperience Pro
Patients in whom treatment with (Xperience Pro) has been attempted

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xperience Pro PMCF Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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