MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)

Study Overview
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Brief Summary
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The retrospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world setting including high volume PCI centers in Italy

Detailed Description
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Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents. The aim of this observational retrospective study is to investigate the clinical performance and long-term safety of scaffold in a real world setting. Institution involved in the present registry are high volume PCI centers. Operators have experience in PCI with bioresorbable scaffolds technology The study organization is based on: DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. In case of clinical events, coronary artery angiographies and percutaneous coronary interventions was reviewed by an independent core-lab.

Official Title
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Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)

Conditions
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Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Device: Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects >18 years Able to provide an informed consent implantation of at least one scaffold Exclusion Criteria: inability to provide at least one year follow-up

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scaffold<br>Patients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold Magmaris | Device: Scaffold<br>* implantation of a Magmaris scaffold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Oriented Cardiac Events (DOCE) rate | Rate of DOCE, a composite of cardiovascular death, target vessel myocardial infarction and target lesion revascularization. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death rate | Rate of unexpected death due to cardiac causes | 1 year | 
| Target vessel myocardial infarction rate | Rate of myocardial infarction due to scaffold failure | 1 year | 
| Target lesion revascularization rate | rate of any revascularization of the lesion treated with a scaffold | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioresorbable scaffolds, Magnesium made bioresorbable scaffolds, Magmaris, coronary artery disease, Percutaneous coronary intervention, Myocardia infarction, multivessel coronary disease