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

February 22, 2020 updated by: Enrico Cerrato, San Luigi Gonzaga Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Luigi Gonzaga Hospital

Collaborators

University Hospital of Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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