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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098042
Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
University Hospital of Ferrara
Information provided by (Responsible Party):
Enrico Cerrato, 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

Condition or disease Intervention/treatment
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.


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Study Type : Observational
Actual Enrollment : 173 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 : July 30, 2016
Actual Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

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




Primary Outcome Measures :
  1. Device Oriented Cardiac Events (DOCE) [ Time Frame: 1 year ]
    DOCE is a composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization.


Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: 1 year ]
    unexpected death due to cardiac causes

  2. Target vessel myocardial infarction [ Time Frame: 1 year ]
    a myocardial infarction due to scaffold failure

  3. Target vessel revascularization [ Time Frame: 1 year ]
    any revascularization of the vessel treated with a scaffold



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098042


Locations
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Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
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

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Responsible Party: Enrico Cerrato, MD, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier: NCT04098042     History of Changes
Other Study ID Numbers: 001/2019
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrico Cerrato, 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:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases