NC Xperience PMCF Study( rEPIC04B)

Fundación EPIC59 enrolled

Overview

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

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 NC Xperience 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

NC XperienceDEVICE

Coronary dilatation balloon catheter (non compliant)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario de Getafe

Getafe, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Outcomes

Primary Outcomes

Safety Endpoint. Freedom from Target Lesion Failure

Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)

Time frame: 7 days

Secondary Outcomes

Efficacy Endpoint. freedom from Target Lesion Failure

Freedom from composite of cardiac death, myocardial infarction (MI)and new Target Lesion Revascularization (TLR)

Time frame: 7 days

Freedom from Balloon rupture

Time frame: During percutaneous coronary intervention (PCI)

Freedom from Hypotube rupture

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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