MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Device: Scaffold

• Registration Number: NCT04098042
• Lead Sponsor: San Luigi Gonzaga Hospital

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.

Study Timeline

• Study Start: 2016-07-30
• Primary Completion: 2019-07-30
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-22
• Last Update Posted: 2020-02-25
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Scaffold	Scaffold	Patients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold "Magmaris"

Primary Outcome Measures

Name	Time	Method
Device Oriented Cardiac Events (DOCE) rate	1 year	Rate of DOCE, a composite of cardiovascular death, target vessel myocardial infarction and target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Cardiac death rate	1 year	Rate of unexpected death due to cardiac causes
Target vessel myocardial infarction rate	1 year	Rate of myocardial infarction due to scaffold failure
Target lesion revascularization rate	1 year	rate of any revascularization of the lesion treated with a scaffold

Trial Locations

Locations (2)

University Hospital of Ferrara; 🇮🇹 Cona, Ferrara, Italy

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy; 🇮🇹 Turin, Italy