NAVISCORE PMCF Study ( rEPIC04F )

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

Detailed Description
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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 Naviscore scoring balloon 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.

Official Title
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NAVISCORE Post-Market Clinical Follow-up Study

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Device: Naviscore


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease (CAD)<br> | Device: Naviscore<br>* Patients in whom treatment with (Naviscore) has been attempted<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint. Freedom from Target Lesion Failure (TLF) | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). | 7 days | 
| Freedom from Balloon rupture | Freedom from Balloon rupture | During PCI (Percutaneous Coronary Intervention) | 
| Freedom from Hypotube rupture | Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device) | During PCI (Percutaneous Coronary Intervention) | 
| Freedom from Complicated withdrawal | Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications) | During PCI (Percutaneous Coronary Intervention) | 
| Freedom from Coronary perforation | Freedom from Coronary perforation according to the modified Ellis classification | During PCI (Percutaneous Coronary Intervention) | 
| Freedom from Coronary dissection >C | Freedom from Coronary dissection >C according to the NHLBI Classification (National Heart, Lung, and Blood Institute) | During PCI (Percutaneous Coronary Intervention) | 
| Freedom from No reflow | Freedom from No reflow (persistently slowed flow with residual stenosis <30% and no flow-limiting dissection) | During PCI (Percutaneous Coronary Intervention) | 
| Freedom from Coronary thrombosis | Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria | During PCI (Percutaneous Coronary Intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter