OCT Guided Magmaris RMS in STEMI

NCT03955731 | Recruiting

• 1 other identifier: 62036
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI

Outcome Measures

Primary Outcomes (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.

  DOCE at 12 months

  1 year

Secondary Outcomes (5)

• 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

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

  2 years

• Definite or probable scaffold thrombosis.

  2 years

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

  15 months

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

  2 years

Study Arms (1)

Single study arm

OTHER

STEMI Patients treated with Magmaris resorbable magnesium scaffold

Device: Magmaris resorbable magnesium scaffold

Interventions

Magmaris resorbable magnesium scaffold DEVICE

Implantation of Magmaris resorbable magnesium scaffold

Single study arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Johan Bennett

Leuven, Brabant, 3001, Belgium

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Johan Bennett, Dr.

CONTACT

+3216342465; johan.bennett@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: May 20, 2019
• Study Start: February 15, 2019
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)