Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID03955731

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

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Implementation

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)

Follow-up

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

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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

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