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

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

Treatments tested in this trial

  • Magmaris resorbable magnesium scaffold

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

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