Coronary Artery DiseaseMAGICNCT04098042
MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)
An observational study of Coronary Artery Disease and Myocardial Infarction, run by San Luigi Gonzaga Hospital at 2 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Scaffold
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Jul 2016to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Who may be able to join
- subjects >18 years
- Able to provide an informed consent
- implantation of at least one scaffold
Who cannot join
- inability to provide at least one year follow-up
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University Hospital of Ferrara
Cona, Ferrara, 44124
Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
Turin, 10100
About this study
Official title: 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
Read the 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.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Scaffold
- Keywords
- Bioresorbable scaffolds, Magnesium made bioresorbable scaffolds, Magmaris, coronary artery disease, Percutaneous coronary intervention, Myocardia infarction, multivessel coronary disease
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScaffoldDevice
implantation of a Magmaris scaffold
| Study group | Role | What they receive |
|---|---|---|
| Scaffold | Patients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold "Magmaris" Receives: Device: Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Oriented Cardiac Events (DOCE) rate
Rate of DOCE, a composite of cardiovascular death, target vessel myocardial infarction and target lesion revascularization.
Measured: 1 year
Secondary outcomes (3)
Cardiac death rate
Rate of unexpected death due to cardiac causes
Measured: 1 year
Target vessel myocardial infarction rate
Rate of myocardial infarction due to scaffold failure
Measured: 1 year
Target lesion revascularization rate
rate of any revascularization of the lesion treated with a scaffold
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start30 Jul 2016
- Primary completion30 Jul 2019
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Ferrara
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098042
- Sponsor's protocol ID
- 001/2019
- Acronym
- MAGIC
- Status last verified
- Feb 2020
- First submitted
- 9 Sep 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)
- ClinicalTrials.gov ID
- NCT04098042
- Acronym / sponsor ID
- MAGIC / 001/2019
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (actual)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Collaborators
- University Hospital of Ferrara
- Study start
- 30 Jul 2016 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scaffold | – | Device: ScaffoldPatients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold "Magmaris" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Key inclusion criteria (3 listed)
- subjects >18 years
- Able to provide an informed consent
- implantation of at least one scaffold
Key exclusion criteria (1 listed)
- inability to provide at least one year follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaffoldimplantation of a Magmaris scaffold | Device | Scaffold |
Primary outcome
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.
3 secondary outcomes
Cardiac death rate
Time frame: 1 year
Target vessel myocardial infarction rate
Time frame: 1 year
Target lesion revascularization rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by San Luigi Gonzaga Hospital at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Oriented Cardiac Events (DOCE) rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.