Coroflex® ISAR NEO PMCF Study

Study Overview
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Brief Summary
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International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Detailed Description
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The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent 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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Coroflex® ISAR NEO Coronary Stent System 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: Coroflex® ISAR NEO coronary stent system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coroflex® ISAR NEO is intended to be used for Patients must be at least 18 years of age AND The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND Patients with Novo lesion length 2-4 mm AND Informed consent signed Exclusion Criteria: Patients with express refusal by the patient to participate in the study. Patients pregnant women and lactating women. Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4). Patients with contraindications or hypersensitivity to sirolimus. Patients with a life expectancy of less than 2 years. Patients included in other clinical trials.

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) and high risk of bleeding<br> | Device: Coroflex® ISAR NEO coronary stent system<br>* Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted<br>|
| Coronary Artery Disease (CAD)<br> | Device: Coroflex® ISAR NEO coronary stent system<br>* Patients in whom treatment with Coroflex® ISAR NEO coronary stent system 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, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR) | 7 days | 
| Efficacy 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 |
| --- | --- | --- |
| Freedom from Accidental dislodgement of the stent | Freedom from Accidental dislodgement of the stent | During percutaneous coronary intervention (PCI) | 
| Freedom from Balloon rupture | Freedom from Balloon rupture | During 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), Drug Eluting Stent