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OCT Guided Magmaris RMS in STEMI

NCT03955731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-03

No results posted yet for this study

Summary

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.

Conditions

  • STEMI

Interventions

DEVICE

Magmaris resorbable magnesium scaffold

Implantation of Magmaris resorbable magnesium scaffold

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Saint Pierre

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • CHU de Charleroi

    collaborator OTHER

  • Jolimont

    collaborator UNKNOWN

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • University Hospital St Luc, Brussels

    collaborator OTHER

  • Centre Hospitalier Universitaire UCLouvain Namur

    collaborator OTHER

  • Le centre hospitalier EpiCURA

    collaborator UNKNOWN

  • Centre Hospitalier Régional de la Citadelle

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2025-02-15
Completion
2025-02-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955731 on ClinicalTrials.gov