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OCT Guided Magmaris RMS in STEMI (BESTMAG)

Primary Purpose

STEMI

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Magmaris resorbable magnesium scaffold

About this trial

This is an interventional treatment trial for STEMI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Age < 18 or > 70 years.
Pregnancy or breastfeeding.
Cardiogenic shock.
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.
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
Non-optimal vessel preparation after predilatation: residual stenosis >30%.
Culprit lesion length > 21 mm.
Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
Culprit lesion involving a saphenous vein graft.
Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
Ostial right coronary artery
Severe calcification or tortuosity of the infarct-related artery.
Absolute contraindication to a 12 months dual antiplatelet therapy.
Life expectancy < 3 years.
Patients taking oral anticoagulant therapy

Sites / Locations

Johan BennettRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single study arm

Arm Description

STEMI Patients treated with Magmaris resorbable magnesium scaffold

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

DOCE at 1-,6- and 24-months follow-up periods.

DOCE at 1,6 and 24 months

Definite or probable scaffold thrombosis.

incidence scaffold thrombosis

Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres

Healing characteristics on OCT evaluation

All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.

MACE

Full Information

NCT ID

NCT03955731

First Posted

February 11, 2019

Last Updated

May 16, 2019

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Centre Hospitalier Universitaire Saint Pierre, Universitair Ziekenhuis Brussel, CHU de Charleroi, Jolimont, Ziekenhuis Oost-Limburg, University Hospital St Luc, Brussels, Centre Hospitalier Universitaire UCLouvain Namur, Le centre hospitalier EpiCURA, Centre Hospitalier Régional de la Citadelle

1. Study Identification

Unique Protocol Identification Number

NCT03955731

Brief Title

OCT Guided Magmaris RMS in STEMI

Acronym

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).

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

February 15, 2020 (Anticipated)

Study Completion Date

February 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

STEMI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single study arm

Arm Type

Other

Arm Description

STEMI Patients treated with Magmaris resorbable magnesium scaffold

Intervention Type

Device

Intervention Name(s)

Magmaris resorbable magnesium scaffold

Intervention Description

Implantation of Magmaris resorbable magnesium scaffold

Primary Outcome Measure Information:

Title

Description

DOCE at 12 months

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation.

Description

Procedure succes

Time Frame

in-hospital

Title

DOCE at 1-,6- and 24-months follow-up periods.

Description

DOCE at 1,6 and 24 months

Time Frame

2 years

Title

Definite or probable scaffold thrombosis.

Description

incidence scaffold thrombosis

Time Frame

2 years

Title

Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres

Description

Healing characteristics on OCT evaluation

Time Frame

15 months

Title

All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.

Description

MACE

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms. Signed patient informed consent. Exclusion Criteria: Age < 18 or > 70 years. Pregnancy or breastfeeding. Cardiogenic shock. 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. 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 Non-optimal vessel preparation after predilatation: residual stenosis >30%. Culprit lesion length > 21 mm. Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis). Culprit lesion involving a saphenous vein graft. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy. Ostial right coronary artery Severe calcification or tortuosity of the infarct-related artery. Absolute contraindication to a 12 months dual antiplatelet therapy. Life expectancy < 3 years. Patients taking oral anticoagulant therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Johan Bennett, Dr.

Phone

+3216342465

johan.bennett@uzleuven.be

Facility Information:

Facility Name

Johan Bennett

City

Leuven

State/Province

Brabant

ZIP/Postal Code

3001

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johan Bennett

Phone

479293854

Ext

479293854

johan.bennett@uzleuven.be

First Name & Middle Initial & Last Name & Degree

Keir McCutcheon

12. IPD Sharing Statement

Learn more about this trial

OCT Guided Magmaris RMS in STEMI

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