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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04098042
Acronym
MAGIC
Enrollment
175
Registered
2019-09-20
Start date
2016-07-30
Completion date
2023-07-30
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction

Keywords

Bioresorbable scaffolds, Magnesium made bioresorbable scaffolds, Magmaris, coronary artery disease, Percutaneous coronary intervention, Myocardia infarction, multivessel coronary disease

Brief 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.

Interventions

DEVICEScaffold

implantation of a Magmaris scaffold

Sponsors

University Hospital of Ferrara
CollaboratorOTHER
San Luigi Gonzaga Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Device Oriented Cardiac Events (DOCE) rate1 yearRate of DOCE, a composite of cardiovascular death, target vessel myocardial infarction and target lesion revascularization.

Secondary

MeasureTime frameDescription
Cardiac death rate1 yearRate of unexpected death due to cardiac causes
Target vessel myocardial infarction rate1 yearRate of myocardial infarction due to scaffold failure
Target lesion revascularization rate1 yearrate of any revascularization of the lesion treated with a scaffold

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026