OCT Guided Magmaris RMS in STEMI

ConditionSTEMI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Magmaris resorbable magnesium scaffold

    Device

    Implantation of Magmaris resorbable magnesium scaffold

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single study armOther 1 intervention

Trial outcomes

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.

DOCE at 12 months

Time frame
1 year

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.

Procedure succes

Time frame
in-hospital
2

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

DOCE at 1,6 and 24 months

Time frame
2 years
3

Definite or probable scaffold thrombosis.

incidence scaffold thrombosis

Time frame
2 years
4

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

Healing characteristics on OCT evaluation

Time frame
15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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