Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT03955731

OCT Guided Magmaris RMS in STEMI

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

100

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

C

Centre Hospitalier Universitaire Saint Pierre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

OCT Guided Magmaris RMS in STEMI

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
  • Signed patient informed consent.
Not Eligible

You will not qualify if you...

  • Age under 18 or over 70 years.
  • Pregnancy or breastfeeding.
  • Cardiogenic shock.
  • Creatinine clearance ≤30 ml/min/1.73 m2 (except for patients on chronic dialysis).
  • Infarct-artery reference diameter < 2.7 mm or > 4.0 mm and OCT infarct-artery distal reference mean lumen diameter < 2.7 mm or > 3.7 mm.
  • Residual stenosis >30% after vessel predilatation.
  • Culprit lesion length > 21 mm.
  • Culprit lesion within a previously stented segment.
  • Culprit lesion involving a saphenous vein graft.
  • Culprit lesion involving a bifurcation requiring a two-stent strategy.
  • Ostial right coronary artery lesion.
  • Severe calcification or tortuosity of the infarct-related artery.
  • Absolute contraindication to 12 months of dual antiplatelet therapy.
  • Life expectancy less than 3 years.
  • Patients taking oral anticoagulant therapy.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johan Bennett

Leuven, Brabant, Belgium, 3001

Actively Recruiting

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Research Team

J

Johan Bennett, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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