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Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Primary Purpose

ST Elevation Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Bioresorbable vascular scaffold
Everolimus eluting stent
Sponsored by
San Giuseppe Moscati Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Acute Myocardial Infarction focused on measuring myocardial infarction, primary PCI, stent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Cardiology Ao Moscati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bioresorbable Vascular Scaffold

Everolimus Eluting stent

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2014
Last Updated
May 30, 2014
Sponsor
San Giuseppe Moscati Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02151929
Brief Title
Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction
Official Title
Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Giuseppe Moscati Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Acute Myocardial Infarction
Keywords
myocardial infarction, primary PCI, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioresorbable Vascular Scaffold
Arm Type
Experimental
Arm Description
Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI
Arm Title
Everolimus Eluting stent
Arm Type
Active Comparator
Arm Description
Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI
Intervention Type
Device
Intervention Name(s)
Bioresorbable vascular scaffold
Other Intervention Name(s)
BVS, ABSORB (Abbot Vascular)
Intervention Description
stenting of an acute thrombotic lesion in patient within STEMI
Intervention Type
Device
Intervention Name(s)
Everolimus eluting stent
Other Intervention Name(s)
Xience Prime (Abbott Vascular)
Intervention Description
stenting of an acute thrombotic lesion in patient within STEMI
Primary Outcome Measure Information:
Title
Procedural and Clinical success
Description
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 Outcome Measure Information:
Title
The MACE
Description
cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
stent thrombosis
Description
cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio Di Lorenzo, MD PhD
Organizational Affiliation
Division of Cardiology AO Moscati Avellino ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology Ao Moscati
City
Avellino
ZIP/Postal Code
83100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21792636
Citation
Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. doi: 10.1007/s11886-011-0207-0.
Results Reference
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PubMed Identifier
22529227
Citation
De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. doi: 10.1001/archinternmed.2012.758.
Results Reference
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PubMed Identifier
19781402
Citation
Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.
Results Reference
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PubMed Identifier
19539255
Citation
Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial. JACC Cardiovasc Interv. 2009 Jun;2(6):515-23. doi: 10.1016/j.jcin.2009.03.012.
Results Reference
background
PubMed Identifier
18342684
Citation
Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
Results Reference
background
PubMed Identifier
21098436
Citation
Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.
Results Reference
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Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

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