OCT Guided Magmaris RMS in STEMI

STEMI Clinical Trial

— BESTMAG  

Official title:

Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold: the BEST- MAG Multicentre Study. (BElgian ST-segment Elevation Myocardial Infarction Treatment With Resorbable MAGnesium Scaffold).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03955731
• Other study ID #: 62036
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: February 15, 2022

Study information

• Verified date: January 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Johan Bennett, Dr.
• Phone: +3216342465
• Email: johan.bennett[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Device:
• Magmaris resorbable magnesium scaffold
Implantation of Magmaris resorbable magnesium scaffold

Locations

Country	Name	City	State
Belgium	Johan Bennett	Leuven	Brabant

Sponsors (10)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur, Centre Hospitalier Universitaire Saint Pierre, CHU de Charleroi, Jolimont, Le centre hospitalier EpiCURA, Universitair Ziekenhuis Brussel, University Hospital St Luc, Brussels, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

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