Navitian PMCF Study ( rEPIC04C )

Fundación EPIC102 enrolled

Overview

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

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 Navitian 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

102

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Interventions

NavitianDEVICE

Patients in whom treatment with (Navitian) has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient treated with Navitian according to routine hospital practice and following instructions for use * Informed consent signed Exclusion Criteria: * Not meet inclusion criteria

Locations (8)

Centro Hospitalar Vila Nova de Gaia

Vila Nova de Gaia, Portugal

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

Outcomes

Primary Outcomes

Safety Endpoint. Freedom fromTarget Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Time frame: 7 days

Secondary Outcomes

Efficacy Endpoint. Freedom from Target Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Time frame: 7 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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