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

NCT ID: NCT01875835

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DES

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

Group Type ACTIVE_COMPARATOR

Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)

Intervention Type DEVICE

BMS

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

Group Type ACTIVE_COMPARATOR

Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

Intervention Type DEVICE

Interventions

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Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)

Intervention Type DEVICE

Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yu Bo

The second affiliated hospitai of Harbin medical university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Locations

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The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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HMUOCT-STEMI

Identifier Type: -

Identifier Source: org_study_id