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

November 27, 2024 updated by: Yu Bo, Harbin Medical University

Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DES
Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
Active Comparator: BMS
Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
Time Frame: 3-month
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.
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Time Frame: 12-month
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.
12-month
Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Time Frame: 3-month
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.
3-month
Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Time Frame: 12-month
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.
12-month
Major adverse cardiovascular events (MACE)
Time Frame: 12-month
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Investigators

  • Principal Investigator: Bo Yu, MD,PhD, The Second Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimated)

June 12, 2013

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMUOCT-STEMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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