MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC) (MAGIC)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10100
    • Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • University Hospital of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital
• Collaborators: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2016
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ANTICIPATED): July 30, 2023

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 22, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: coronary artery disease; Percutaneous coronary intervention; multivessel coronary disease; Magmaris; Bioresorbable scaffolds; Magnesium made bioresorbable scaffolds; Myocardia infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 001/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No