Using a resorbable magnesium scaffold for treating heart attacks

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).

This study is testing a new magnesium scaffold to see if it can safely help people who have had a heart attack feel better and avoid complications compared to regular stents.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 1 site (Leuven, Brabant)
• Trial ID: NCT03955731 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of the Magmaris resorbable magnesium scaffold for patients experiencing ST-elevation myocardial infarction (STEMI). The study aims to evaluate the safety and efficacy of this bioresorbable scaffold compared to traditional stents, focusing on its potential to reduce complications such as stent thrombosis. Patients will undergo intra-coronary imaging and will be followed for long-term clinical outcomes. The trial is designed as a multicenter approach to gather comprehensive data on the scaffold's performance in real-world settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 who are experiencing STEMI with symptoms onset within the last 24 hours.

Not a fit: Patients with severe renal impairment, those over 70 years old, or those with specific anatomical challenges related to their coronary arteries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients with STEMI by reducing the risk of complications associated with permanent stents.

How similar studies have performed: Previous studies have shown favorable outcomes with bioresorbable scaffolds, suggesting that this approach may be promising, although the specific use of Magmaris in STEMI is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<24 hours or with ongoing symptoms.
2. Signed patient informed consent.

Exclusion Criteria:

1. Age \< 18 or \> 70 years.
2. Pregnancy or breastfeeding.
3. Cardiogenic shock.
4. 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.
5. 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
6. Non-optimal vessel preparation after predilatation: residual stenosis \>30%.
7. Culprit lesion length \> 21 mm.
8. Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
9. Culprit lesion involving a saphenous vein graft.
10. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
11. Ostial right coronary artery
12. Severe calcification or tortuosity of the infarct-related artery.
13. Absolute contraindication to a 12 months dual antiplatelet therapy.
14. Life expectancy \< 3 years.
15. Patients taking oral anticoagulant therapy

Where this trial is running

Leuven, Brabant

• Johan Bennett — Leuven, Brabant, Belgium (RECRUITING)

Study contacts

• Study coordinator: Johan Bennett, Dr.

Conditions: STEMI