MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)

• Sponsor: San Luigi Gonzaga Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04098042
• Collaborator: University Hospital of Ferrara (Other)
• Enrollment: 175
• Locations: 2
• Anticipated Duration (Months): 84
• Patients Per Site: 87.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Myocardial Infarction	Device: Scaffold

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 Design

• Study Type: Observational
• Actual Enrollment: 175 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)
• Actual Study Start Date: Jul 30, 2016
• Actual Primary Completion Date: Jul 30, 2019
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Scaffold Patients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold "Magmaris"	Device: Scaffold; implantation of a Magmaris scaffold

Outcome Measures

Primary Outcome Measures

1. 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

1. Cardiac death rate [1 year]

   Rate of unexpected death due to cardiac causes

2. Target vessel myocardial infarction rate [1 year]

   Rate of myocardial infarction due to scaffold failure

3. Target lesion revascularization rate [1 year]

   rate of any revascularization of the lesion treated with a scaffold

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Ferrara	Cona	Ferrara	Italy	44124
2	Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy	Turin		Italy	10100

Sponsors and Collaborators

• San Luigi Gonzaga Hospital
• University Hospital of Ferrara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enrico Cerrato, MD, San Luigi Gonzaga Hospital
• ClinicalTrials.gov Identifier: NCT04098042
• Other Study ID Numbers: 001/2019
• First Posted: Sep 20, 2019
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Enrico Cerrato, MD, San Luigi Gonzaga Hospital: Bioresorbable scaffolds; Magnesium made bioresorbable scaffolds; Magmaris; coronary artery disease; Percutaneous coronary intervention; Myocardia infarction; multivessel coronary disease
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction

Study Results

No Results Posted as of Feb 25, 2020