Actively Recruiting
Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold: the BEST-MAG Multicentre Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
C
Centre Hospitalier Universitaire Saint Pierre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of a bioresorbable magnesium scaffold called Magmaris for treating patients with ST-segment elevation myocardial infarction (STEMI), a type of heart attack. This study explores the potential advantages of Magmaris over permanent bare-metal or drug-eluting stents due to its ability to dissolve over time. Early findings suggest Magmaris may have a lower risk of blood clots compared to other bioresorbable scaffolds, making it a promising option for patients with STEMI. Participants will receive the Magmaris resorbable magnesium scaffold implanted in the affected coronary artery segment. The study involves a single treatment group where all STEMI patients receive this device. The research includes intracoronary imaging with optical coherence tomography (OCT) to monitor the vessel and scaffold, with follow-up procedures planned to assess vessel healing and device performance. During the study, participants will be monitored for outcomes such as cardiac death, heart attacks related to the treated vessel, and the need for further procedures on the target lesion within 12 months. Additional evaluations include procedural success, scaffold thrombosis, and broader cardiac events up to two years. Imaging with OCT at 15 months will assess vessel healing. The total study duration includes regular follow-ups over two years, ensuring close observation of safety and effectiveness measures.
CONDITIONS
Brief Title
OCT Guided Magmaris RMS in STEMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting with ST-elevation myocardial infarction (STEMI) with symptom onset less than 24 hours or ongoing symptoms
- Signed informed consent
- Age between 18 and 70 years
You will not qualify if you...
- Age under 18 or over 70 years
- Pregnancy or breastfeeding
- Cardiogenic shock
- Creatinine clearance below 30 ml/min/1.73 m2 and not on dialysis
- Infarct-artery reference diameter outside 2.7 to 4.0 mm by visual estimation
- OCT infarct-artery distal reference mean lumen diameter outside 2.7 to 3.7 mm
- Residual stenosis greater than 30% after vessel preparation
- Culprit lesion length greater than 21 mm
- Culprit lesion within previously stented segment
- Culprit lesion involving a saphenous vein graft
- Culprit lesion involving bifurcation requiring two-stent strategy
- Ostial right coronary artery lesion
- Severe calcification or tortuosity of infarct-related artery
- Absolute contraindication to 12 months dual antiplatelet therapy
- Life expectancy less than 3 years
- Current use of oral anticoagulant therapy (blood thinners)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
/null
Duration - In-hospital
Participants receive implantation of the Magmaris resorbable magnesium scaffold to treat ST-segment elevation myocardial infarction (STEMI).
1 procedure visit (in-person)
Duration - Up to 24 months
Participants are monitored for device oriented composite endpoints and vessel healing through angiographic and OCT assessments.
Follow-up visits at 1, 6, 12, 15, and 24 months (in-person)
Trial Site Locations
Total: 1 location
1
Johan Bennett
Leuven, Brabant, Belgium, 3001
Actively Recruiting
Research Team
J
Johan Bennett, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here