OCT Guided Magmaris RMS in STEMI

Not Applicable

Recruiting

• Conditions: STEMI

• Registration Number: NCT03955731
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study Start: 2019-02-15
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-02-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure.	1 year	DOCE at 12 months

Secondary Outcome Measures

Name	Time	Method
Definite or probable scaffold thrombosis.	2 years	incidence scaffold thrombosis
DOCE at 1-,6- and 24-months follow-up periods.	2 years	DOCE at 1,6 and 24 months
Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres	15 months	Healing characteristics on OCT evaluation
Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation.	in-hospital	Procedure succes
All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.	2 years	MACE

Trial Locations

Locations (1)

Johan Bennett; 🇧🇪 Leuven, Brabant, Belgium