STEMI
Conditions
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.
Interventions
DEVICEMagmaris resorbable magnesium scaffold
Implantation of Magmaris resorbable magnesium scaffold
Sponsors
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
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| DOCE at 1-,6- and 24-months follow-up periods. | 2 years | DOCE at 1,6 and 24 months |
| Definite or probable scaffold thrombosis. | 2 years | incidence scaffold thrombosis |
| 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 |
| All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months. | 2 years | MACE |
Countries
Belgium
Contacts
Primary ContactJohan Bennett, Dr.
Outcome results
None listed