Navitian PMCF Study ( rEPIC04C )

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 Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.

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 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.

Official Title
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Navitian Post-Market Clinical Follow-up Study

Conditions
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Coronary Artery Disease (CAD), Ischemic Heart Disease

Intervention / Treatment
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* Device: Navitian


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Navitian<br>* Patients in whom treatment with (Navitian) 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 fromTarget Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 7 days | 
| Freedom from Device rupture | Freedom from Device rupture | During percutaneous coronary intervention (PCI) | 
| Freedom from Kinking | Freedom from Kinking | During PCI | 
| Freedom from Complicated withdrawal | Freedom from Complicated withdrawal | During PCI | 
| Freedom from Coronary perforation | Freedom from Coronary perforation | During PCI | 
| Freedom from Coronary dissection >C | Freedom from Coronary dissection >C | During PCI | 
| Freedom from No reflow | Freedom from No reflow | During PCI | 
| Freedom from Coronary thrombosis | Freedom from Coronary thrombosis | During PCI | 

 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 microcatheter