BESTMAG: OCT Guided Magmaris RMS in STEMI

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03955731
• Collaborator: Centre Hospitalier Universitaire Saint Pierre (Other), Universitair Ziekenhuis Brussel (Other), CHU de Charleroi (Other), Jolimont (Other), Ziekenhuis Oost-Limburg (Other), University Hospital St Luc, Brussels (Other), Centre Hospitalier Universitaire Dinant Godinne - UCL Namur (Other), Le centre hospitalier EpiCURA (Other), Centre Hospitalier Régional de la Citadelle (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
STEMI	Device: Magmaris resorbable magnesium scaffold	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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).
• Actual Study Start Date: Feb 15, 2019
• Anticipated Primary Completion Date: Feb 15, 2020
• Anticipated Study Completion Date: Feb 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. DOCE at 1-,6- and 24-months follow-up periods. [2 years]

   DOCE at 1,6 and 24 months

3. Definite or probable scaffold thrombosis. [2 years]

   incidence scaffold thrombosis

4. 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

5. All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months. [2 years]

   MACE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johan Bennett	Leuven	Brabant	Belgium	3001

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03955731
• Other Study ID Numbers: 62036
• First Posted: May 20, 2019
• Last Update Posted: May 20, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: ST Elevation Myocardial Infarction

Study Results

No Results Posted as of May 20, 2019