About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
Signed patient informed consent.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Magmaris resorbable magnesium scaffold
DeviceImplantation of Magmaris resorbable magnesium scaffold
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Procedure succes
DOCE at 1-,6- and 24-months follow-up periods.
DOCE at 1,6 and 24 months
Definite or probable scaffold thrombosis.
incidence scaffold thrombosis
Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres
Healing characteristics on OCT evaluation
Sponsors and contacts
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborator
Universitair Ziekenhuis Brussel
Collaborator
CHU de Charleroi
Collaborator
Jolimont
Collaborator
Ziekenhuis Oost-Limburg
Collaborator
University Hospital St Luc, Brussels
Collaborator
Centre Hospitalier Universitaire UCLouvain Namur
Collaborator
Le centre hospitalier EpiCURA
Collaborator
Centre Hospitalier Régional de la Citadelle
Collaborator