OCT Guided Magmaris RMS in STEMI

Last updated: July 2, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiovascular Disease

Heart Disease

Congestive Heart Failure

Treatment

Magmaris resorbable magnesium scaffold

Clinical Study ID

NCT03955731
62036
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptomsonset <24 hours or with ongoing symptoms.

  2. Signed patient informed consent.

Exclusion

Exclusion Criteria:

  1. Age < 18 or > 70 years.

  2. Pregnancy or breastfeeding.

  3. Cardiogenic shock.

  4. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimatedGFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible forenrolment regardless of creatinine clearance.

  5. Infarct-artery reference diameter < 2.7 or > 4.0 mm (within the segment of theculprit lesion) by visual estimation, and OCT infarct-artery distal reference meanlumen diameter < 2.7 or > 3.7 mm

  6. Non-optimal vessel preparation after predilatation: residual stenosis >30%.

  7. Culprit lesion length > 21 mm.

  8. Culprit lesion located within a previously stented segment (stent thrombosis orin-stent restenosis).

  9. Culprit lesion involving a saphenous vein graft.

  10. Culprit lesion involving a bifurcation with an intended two-stent implantationstrategy.

  11. Ostial right coronary artery

  12. Severe calcification or tortuosity of the infarct-related artery.

  13. Absolute contraindication to a 12 months dual antiplatelet therapy.

  14. Life expectancy < 3 years.

  15. Patients taking oral anticoagulant therapy

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Magmaris resorbable magnesium scaffold
Phase:
Study Start date:
February 15, 2019
Estimated Completion Date:
February 15, 2025

Connect with a study center

  • Johan Bennett

    Leuven, Brabant 3001
    Belgium

    Active - Recruiting

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