NC Xperience PMCF Study( rEPIC04B)

Study Overview
=================
Brief Summary
-----------------
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 .

Detailed Description
-----------------
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.

Official Title
-----------------
NC Xperience Post-Market Clinical Follow-up Study

Conditions
-----------------
Coronary Artery Disease (CAD), Ischemic Heart Disease

Intervention / Treatment
-----------------
* Device: NC Xperience


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease (CAD)<br> | Device: NC Xperience<br>* Coronary dilatation balloon catheter (non compliant)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint. freedom from Target Lesion Failure | Freedom from composite of cardiac death, myocardial infarction (MI)and new Target Lesion Revascularization (TLR) | 7 days | 
| 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter