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Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography (NeoCover)

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardiac infarction, Bare-metal stent, Everolimus-eluting stent, Optical coherence tomography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18-75 years
  • Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
  • Length of culprit lesion≤25mm.
  • Vessel size in between 2.5 and 4.0 mm.
  • Signed patient informed consent.

Exclusion Criteria:

  • Prior administration of thrombolytic therapy.
  • Cardiogenic shock.
  • Renal failure (Crea≥2.0mg/dL).
  • Recent major bleeding.
  • Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
  • Left main disease
  • Multi-vessel lesion
  • Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
  • Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
  • No suitable anatomy for OCT scan.

Sites / Locations

  • The Second Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DES

BMS

Arm Description

Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)

Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)

Outcomes

Primary Outcome Measures

Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.

Secondary Outcome Measures

Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
Major adverse cardiovascular events (MACE)

Full Information

First Posted
June 5, 2013
Last Updated
December 19, 2016
Sponsor
Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01875835
Brief Title
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
Acronym
NeoCover
Official Title
Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs. However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardiac infarction, Bare-metal stent, Everolimus-eluting stent, Optical coherence tomography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DES
Arm Type
Active Comparator
Arm Description
Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Arm Title
BMS
Arm Type
Active Comparator
Arm Description
Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Intervention Type
Device
Intervention Name(s)
Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
Intervention Type
Device
Intervention Name(s)
Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
Primary Outcome Measure Information:
Title
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
Description
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
Time Frame
3-month
Secondary Outcome Measure Information:
Title
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Description
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
Time Frame
12-month
Title
Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Description
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
Time Frame
3-month
Title
Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Description
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
Time Frame
12-month
Title
Major adverse cardiovascular events (MACE)
Time Frame
12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-75 years Acute MI with ST-segment elevation, within 12 hours from symptoms onset. Length of culprit lesion≤25mm. Vessel size in between 2.5 and 4.0 mm. Signed patient informed consent. Exclusion Criteria: Prior administration of thrombolytic therapy. Cardiogenic shock. Renal failure (Crea≥2.0mg/dL). Recent major bleeding. Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media. Left main disease Multi-vessel lesion Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches) Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts. No suitable anatomy for OCT scan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD,PhD
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China

12. IPD Sharing Statement

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Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography

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