Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

San Giuseppe Moscati Hospital

Status and phase: Completed; Phase 4

Conditions: ST Elevation Acute Myocardial Infarction

Treatments: Device: Everolimus eluting stent; Device: Bioresorbable vascular scaffold

Study type: Interventional

Funder types: Other

Identifiers

NCT02151929

AOM_BVS1

Details and patient eligibility

About

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Full description

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. chest pain for more than 30 minutes;
2. ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

Exclusion criteria

1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
2. Contraindication to dual antiplatelet therapy for 12 months;
3. Known allergy to everolimus;
4. A history of stroke within 30 days or any history of hemorrhagic stroke;
5. History, symptoms, or findings suggestive of aortic dissection;
6. High-likelihood of death within BVS resorbtion time;
7. Cardiogenic shock;
8. Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes);
9. Pregnancy;
10. Participation in other trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Bioresorbable Vascular Scaffold

Experimental group

Description:

Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI

Treatment:

Device: Bioresorbable vascular scaffold

Everolimus Eluting stent

Active Comparator group

Description:

Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI

Treatment:

Device: Everolimus eluting stent