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NCT Number: NCT03955731

OCT Guided Magmaris RMS in STEMI

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.

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Key information

Conditions

STEMI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johan Bennett

Leuven, Brabant, 3001, Belgium

Location status: Recruiting

Location contact

Johan Bennett

CONTACT

[email protected]

479293854 ext. 479293854

Keir McCutcheon

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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%.
  • 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

Treatment and study plan

Magmaris resorbable magnesium scaffold

Device

Implantation of Magmaris resorbable magnesium scaffold

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Procedure succes

  2. DOCE at 1-,6- and 24-months follow-up periods.

    Time frame: 2 years

    DOCE at 1,6 and 24 months

  3. Definite or probable scaffold thrombosis.

    Time frame: 2 years

    incidence scaffold thrombosis

  4. Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres

    Time frame: 15 months

    Healing characteristics on OCT evaluation

  5. All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.

    Time frame: 2 years

    MACE

Study contacts

Contact information is provided by the study sponsor or research team.

Johan Bennett, Dr.

CONTACT

[email protected]

+3216342465

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • CHU de Charleroi
  • Centre Hospitalier Régional de la Citadelle
  • Centre Hospitalier Universitaire Saint Pierre
  • Centre Hospitalier Universitaire UCLouvain Namur
  • Jolimont
  • Le centre hospitalier EpiCURA
  • Universitair Ziekenhuis Brussel
  • University Hospital St Luc, Brussels
  • Ziekenhuis Oost-Limburg

Registry information

Official study 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).

Acronym: BESTMAG

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 20, 2019
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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