e-BioMatrix PostMarket Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

Detailed Description
-----------------
Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.

Official Title
-----------------
A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents No limitation on the number of treated lesions, and vessels, and lesion length Exclusion Criteria: Inability to provide informed consent Patients needing additional stent NOT of the Biolimus A9™-eluting stent type Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent thrombosis | Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years; | 30 days, 6 and 12 months, 2, 3 and 5 years | 
| MACE | Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 30 days, 6 months, 2, 3 and 5 years; | 30 days, 6 months, 2, 3 and 5 years; | 
| Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization at 30 days, 6 and 12 months, 2, 3 and 5 years; |  | 6 and 12 months, 2, 3 and 5 years | 
| Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years; |  | 30 days, 6 and 12 months, 2, 3 and 5 years; | 
| Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years; |  | 30 days, 6 and 12 months, 2, 3 and 5 years | 
| Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years. |  | 30 days, 6 and 12 months, 2, 3 and 5 years. |