MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC) (MAGIC)
|ClinicalTrials.gov Identifier: NCT04098042|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Myocardial Infarction||Device: Scaffold|
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.
|Study Type :||Observational|
|Actual Enrollment :||173 participants|
|Official Title:||Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)|
|Actual Study Start Date :||July 30, 2016|
|Actual Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||July 30, 2023|
Patients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold "Magmaris"
implantation of a Magmaris scaffold
- Device Oriented Cardiac Events (DOCE) [ Time Frame: 1 year ]DOCE is a composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization.
- Cardiac death [ Time Frame: 1 year ]unexpected death due to cardiac causes
- Target vessel myocardial infarction [ Time Frame: 1 year ]a myocardial infarction due to scaffold failure
- Target vessel revascularization [ Time Frame: 1 year ]any revascularization of the vessel treated with a scaffold
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098042
|University Hospital of Ferrara|
|Cona, Ferrara, Italy, 44124|
|Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy|
|Turin, Italy, 10100|