OCT Guided Magmaris RMS in STEMI (BESTMAG)

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).

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.

Study Overview

• Status: Unknown
• Conditions: STEMI
• Intervention / Treatment: Device: Magmaris resorbable magnesium scaffold

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan Bennett, Dr.; Phone Number: +3216342465; Email: johan.bennett@uzleuven.be

Study Locations

• Belgium
  • Brabant
    • Leuven, Brabant, Belgium, 3001
      • Recruiting
      • Johan Bennett
      • Contact: Johan Bennett; Phone Number: 479293854 479293854; Email: johan.bennett@uzleuven.be
      • Sub-Investigator: Keir McCutcheon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single study arm; STEMI Patients treated with Magmaris resorbable magnesium scaffold	Device: Magmaris resorbable magnesium scaffold; Implantation of Magmaris resorbable magnesium scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
DOCE at 1-,6- and 24-months follow-up periods.	DOCE at 1,6 and 24 months	2 years
Definite or probable scaffold thrombosis.	incidence scaffold thrombosis	2 years
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
All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.	MACE	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Anticipated): February 15, 2020
• Study Completion (Anticipated): February 15, 2022

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 62036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No