OCT Guided Magmaris RMS in STEMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2025-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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STEMI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single study arm

STEMI Patients treated with Magmaris resorbable magnesium scaffold

Group Type OTHER

Magmaris resorbable magnesium scaffold

Intervention Type DEVICE

Implantation of Magmaris resorbable magnesium scaffold

Interventions

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Magmaris resorbable magnesium scaffold

Implantation of Magmaris resorbable magnesium scaffold

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<24 hours or with ongoing symptoms.
2. Signed patient informed consent.

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 estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
5. Infarct-artery reference diameter \< 2.7 or \> 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen 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 or in-stent restenosis).
9. Culprit lesion involving a saphenous vein graft.
10. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No