CAPTURER PMCF Study ( rEPIC04D )

Completed

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

• Registration Number: NCT05292079
• 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 CAPTURER to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with CAPTURER .

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 CAPTURER 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: 2022-09-29
• Primary Completion: 2023-12-27
• Study Completion: 2023-12-27
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patient treated with CAPTURER 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)	CAPTURER	-

Primary Outcome Measures

Name	Time	Method
Safety Endpoint. Freedom from Target Lesion Failure	30 days	Freedom from TARGET LESION FAILURE (TLF), composite end point of cardiac death, myocardial infarction, stroke and and new Target Lesion Revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Freedom from Kinking	During PCI	Freedom from Kinking
Freedom from Complicated withdrawal	During PCI	Freedom from Complicated withdrawal
Freedom from No reflow	During PCI	Freedom from No reflow
Freedom from Coronary thrombosis	During PCI	Freedom from Coronary thrombosis
Efficacy Endpoint. Freedom from Target Lesion Failure	30 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and and new Target Lesion Revascularization (TLR)
Freedom from Coronary dissection >C	During PCI	Freedom from Coronary dissection \>C
Freedom from Device rupture	During percutaneous coronary intervention (PCI)	Freedom from Device rupture
Freedom from Coronary perforation	During PCI	Freedom from Coronary perforation

Trial Locations

Locations (5)

H. Puerta Del Mar; 🇪🇸 Cadiz, Spain

Hospital de San Pedro; 🇪🇸 Logroño, Spain

Hospital Universitario Regional de Malaga; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen de La Victoria; 🇪🇸 Málaga, Spain

Hospital Clinico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain