NCT04098042

MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: San Luigi Gonzaga Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Scaffold	implantation of a Magmaris scaffold

Timeline

• Start date: 2016-07-30
• Primary completion: 2019-07-30
• Completion: 2023-07-30
• First posted: 2019-09-20
• Last updated: 2020-02-25

Locations

2 sites across 1 country: Italy