MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)

Coronary Artery Disease Clinical Trial

— MAGIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04098042
• Other study ID #: 001/2019
• Status: Active, not recruiting
• Start date: July 30, 2016
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2020
• Source: San Luigi Gonzaga Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Scaffold
implantation of a Magmaris scaffold

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara	Cona	Ferrara
Italy	Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy	Turin

Sponsors (2)

Lead Sponsor	Collaborator
San Luigi Gonzaga Hospital	University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac death rate	Rate of unexpected death due to cardiac causes	1 year
Secondary	Target vessel myocardial infarction rate	Rate of myocardial infarction due to scaffold failure	1 year
Secondary	Target lesion revascularization rate	rate of any revascularization of the lesion treated with a scaffold	1 year