Clinical trial NCT03955731: OCT Guided Magmaris RMS in STEMI
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
Overall status: RECRUITING
Phase: NA
Conditions: STEMI
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Saint Pierre
name: Universitair Ziekenhuis Brussel
name: CHU de Charleroi
name: Jolimont
name: Ziekenhuis Oost-Limburg
name: University Hospital St Luc, Brussels
name: Centre Hospitalier Universitaire UCLouvain Namur
name: Le centre hospitalier EpiCURA
name: Centre Hospitalier Régional de la Citadelle
First posted: 2019-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation.
timeFrame: in-hospital
measure: DOCE at 1-,6- and 24-months follow-up periods.
timeFrame: 2 years
measure: Definite or probable scaffold thrombosis.
timeFrame: 2 years
measure: Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres
timeFrame: 15 months
measure: All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months.
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Johan Bennett
state: Brabant
Study officials:
References: