Clinical trial NCT04098042: MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)
Official title: Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Myocardial Infarction
Keywords: Bioresorbable scaffolds
Magnesium made bioresorbable scaffolds
Magmaris
coronary artery disease
Percutaneous coronary intervention
Myocardia infarction
multivessel coronary disease
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of Ferrara
First posted: 2019-09-20
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

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

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.

Eligibility 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

Primary outcomes:
measure: Device Oriented Cardiac Events (DOCE) rate
timeFrame: 1 year
Secondary outcomes:
measure: Cardiac death rate
timeFrame: 1 year
measure: Target vessel myocardial infarction rate
timeFrame: 1 year
measure: Target lesion revascularization rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
city: Turin
country: Italy
facility: Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
Study officials:
References: