STEMIBESTMAGNCT03955731
OCT Guided Magmaris RMS in STEMI
A study testing Magmaris resorbable magnesium scaffold in people with STEMI, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- STEMI
- What is being tested?
- Magmaris resorbable magnesium scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2019to 15 Feb 2025
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
- Signed patient informed consent.
Who cannot join
- Age < 18 or > 70 years.
- Pregnancy or breastfeeding.
- Cardiogenic shock.
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
- Infarct-artery reference diameter < 2.7 or > 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter < 2.7 or > 3.7 mm
- Non-optimal vessel preparation after predilatation: residual stenosis >30%.
Show all 15Show fewer
- Culprit lesion length > 21 mm.
- Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
- Culprit lesion involving a saphenous vein graft.
- Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
- Ostial right coronary artery
- Severe calcification or tortuosity of the infarct-related artery.
- Absolute contraindication to a 12 months dual antiplatelet therapy.
- Life expectancy < 3 years.
- Patients taking oral anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Johan Bennett
Leuven, Brabant, 3001
Johan Bennett, 479293854 ext. 479293854, johan.bennett@uzleuven.be
Keir McCutcheon
About this study
Official title: Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold: the BEST- MAG Multicentre Study. (BElgian ST-segment Elevation Myocardial Infarction Treatment With Resorbable MAGnesium Scaffold).
Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.
- Conditions
- STEMI
- Being tested
- Magmaris resorbable magnesium scaffold
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magmaris resorbable magnesium scaffoldDevice
Implantation of Magmaris resorbable magnesium scaffold
| Study group | Role | What they receive |
|---|---|---|
| Single study arm | Other | STEMI Patients treated with Magmaris resorbable magnesium scaffold Receives: Device: Magmaris resorbable magnesium scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure.
DOCE at 12 months
Measured: 1 year
Secondary outcomes (5)
Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation.
Procedure succes
Measured: in-hospital
DOCE at 1-,6- and 24-months follow-up periods.
DOCE at 1,6 and 24 months
Measured: 2 years
Definite or probable scaffold thrombosis.
incidence scaffold thrombosis
Measured: 2 years
Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres
Healing characteristics on OCT evaluation
Measured: 15 months
All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.
MACE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Feb 2019
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre, Universitair Ziekenhuis Brussel, CHU de Charleroi, Jolimont, Ziekenhuis Oost-Limburg, University Hospital St Luc, Brussels, Centre Hospitalier Universitaire UCLouvain Namur, Le centre hospitalier EpiCURA, Centre Hospitalier Régional de la Citadelle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955731
- Sponsor's protocol ID
- 62036
- Acronym
- BESTMAG
- Status last verified
- Jul 2024
- First submitted
- 11 Feb 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold: the BEST- MAG Multicentre Study. (BElgian ST-segment Elevation Myocardial Infarction Treatment With Resorbable MAGnesium Scaffold).
- ClinicalTrials.gov ID
- NCT03955731
- Acronym / sponsor ID
- BESTMAG / 62036
- Conditions
- STEMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre, Universitair Ziekenhuis Brussel, CHU de Charleroi, Jolimont, Ziekenhuis Oost-Limburg, University Hospital St Luc, Brussels, Centre Hospitalier Universitaire UCLouvain Namur, Le centre hospitalier EpiCURA, Centre Hospitalier Régional de la Citadelle
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 20 May 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.
Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single study arm | Other | Device: Magmaris resorbable magnesium scaffoldSTEMI Patients treated with Magmaris resorbable magnesium scaffold |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
- Signed patient informed consent.
Key exclusion criteria (15 listed)
- Age < 18 or > 70 years.
- Pregnancy or breastfeeding.
- Cardiogenic shock.
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
- Infarct-artery reference diameter < 2.7 or > 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter < 2.7 or > 3.7 mm
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 |
|---|---|---|
| Magmaris resorbable magnesium scaffoldImplantation of Magmaris resorbable magnesium scaffold | Device | Single study arm |
Primary outcome
A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure.
Time frame: 1 year
DOCE at 12 months
5 secondary outcomes
Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation.
Time frame: in-hospital
DOCE at 1-,6- and 24-months follow-up periods.
Time frame: 2 years
Definite or probable scaffold thrombosis.
Time frame: 2 years
Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres
Time frame: 15 months
All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Related trials for STEMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magmaris resorbable magnesium scaffold in people with STEMI, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 15 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Contact Johan Bennett, Dr. (+3216342465, johan.bennett@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure. (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 3 Jul 2024.