Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Phase 4CompletedNCT02151929

San Giuseppe Moscati Hospital100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

ST Elevation Acute Myocardial Infarction

Interventions

Bioresorbable vascular scaffoldDEVICE

stenting of an acute thrombotic lesion in patient within STEMI

Everolimus eluting stentDEVICE

stenting of an acute thrombotic lesion in patient within STEMI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Cardiology Ao Moscati

Avellino, Italy

Outcomes

Primary Outcomes

Procedural and Clinical success

Procedural success: The deployment of BVS at the intended target lesion with a final residual stenosis ≤20% and a TIMI 2-3 coronary flow by visual estimation without major periprocedural complication (death, emergent CABG, coronary perforation, flow limiting coronary dissection). Clinical success: any major in-hospital events (deaths, reinfarction, urgent revascularization, stroke, major bleedings)

Time frame: Patients will be followed for the duration of hospital stay (4-8 days)

Secondary Outcomes

The MACE

cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization

Time frame: six months

Data from ClinicalTrials.gov

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