Essential Pro PMCF Study ( rEPIC04E )

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

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 Essential Pro 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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Essential Pro Post-Market Clinical Follow-up Study

Conditions
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Coronary Artery Disease (CAD), Ischemic Heart Disease

Intervention / Treatment
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* Drug: Essential pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient treated with Essential Pro 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> | Drug: Essential pro<br>* Patients in whom treatment with (Essential Pro) 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). | 12 months | 

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). | 12 months | 
| Freedom from Balloon rupture | Freedom from Balloon rupture | During percutaneous coronary intervention (PCI) | 
| Freedom from Hypotube rupture | Freedom from Hypotube rupture | 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), Paclitaxel eluting coronary balloon dilatation catheter