CAPTURER PMCF Study ( rEPIC04D )

N/ACompletedNCT05292079

Fundación EPIC86 enrolled

Overview

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 .

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 Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Interventions

CAPTURERDEVICE

Patients in whom treatment with (CAPTURER) has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Safety Endpoint. Freedom from Target Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite end point of cardiac death, myocardial infarction, stroke and and new Target Lesion Revascularization (TLR)

Time frame: 30 days

Secondary Outcomes

Efficacy Endpoint. Freedom from Target Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and and new Target Lesion Revascularization (TLR)

Time frame: 30 days

Freedom from Device rupture

Time frame: During percutaneous coronary intervention (PCI)

Freedom from Kinking

Time frame: During PCI

Freedom from Complicated withdrawal

Time frame: During PCI

Freedom from Coronary perforation

Time frame: During PCI

Freedom from Coronary dissection >C

Freedom from Coronary dissection \>C

Time frame: During PCI

Freedom from No reflow

Time frame: During PCI

Freedom from Coronary thrombosis

Data from ClinicalTrials.gov

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