Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Sponsor

San Giuseppe Moscati Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02151929

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Acute Myocardial Infarction	Device: Bioresorbable vascular scaffold Device: Everolimus eluting stent	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bioresorbable Vascular Scaffold Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI	Device: Bioresorbable vascular scaffold stenting of an acute thrombotic lesion in patient within STEMI Other Names: BVS, ABSORB (Abbot Vascular)
Active Comparator: Everolimus Eluting stent Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI	Device: Everolimus eluting stent stenting of an acute thrombotic lesion in patient within STEMI Other Names: Xience Prime (Abbott Vascular)

Arm

Intervention/Treatment

Experimental: Bioresorbable Vascular Scaffold

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

Device: Bioresorbable vascular scaffold

stenting of an acute thrombotic lesion in patient within STEMI

Other Names:

BVS, ABSORB (Abbot Vascular)

Active Comparator: Everolimus Eluting stent

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

Device: Everolimus eluting stent

stenting of an acute thrombotic lesion in patient within STEMI

Other Names:

Xience Prime (Abbott Vascular)

Outcome Measures

Primary Outcome Measures

Procedural and Clinical success [Patients will be followed for the duration of hospital stay (4-8 days)]
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)

Secondary Outcome Measures

The MACE [six months]
cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization

Other Outcome Measures

stent thrombosis [six months]
cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

chest pain for more than 30 minutes;
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:

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