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Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent

NCT ID: NCT02014818

Last Updated: 2017-10-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-12-31

Brief Summary

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To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All patients' information will be blinded to OCT image analyzers.

Study Groups

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3 month OCT follow-up, CoCr-EES

Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 3 months after the index procedure.

Group Type EXPERIMENTAL

CoCr-EES

Intervention Type DEVICE

1 month OCT follow-up, CoCr-EES

Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 1 months after the index procedure.

Group Type EXPERIMENTAL

CoCr-EES

Intervention Type DEVICE

Interventions

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CoCr-EES

Intervention Type DEVICE

Other Intervention Names

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XIENCE PRIME XIENCE Xpedition

Eligibility Criteria

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Inclusion Criteria

* Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
* Patients aged 20 to less than 85 years at the time of informed consent
* Patients who have provided informed consent written by themselves
* Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months

Exclusion Criteria

* If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
* Patients with acute myocardial infarction (AMI)
* Patients in a state of shock
* Patients with cardiac failure
* Patients having a culprit lesion in the left main coronary artery trunk
* Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
* Patients having an in-stent restenosis lesion as the culprit lesion
* Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
* Patients on hemodialysis
* Cancer patients with a life expectancy of less than 2 years
* Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
* Pregnant women or women expected to become pregnant
* Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kobe University

INDUSTRY

Sponsor Role lead

Responsible Party

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Toshiro Shinke, MD, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Toshiro Shinke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kobe University Graduate School of Medicine

Locations

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Kobe University Graduate School of Medicine

Kobe, , Japan

Site Status

Countries

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Japan

Other Identifiers

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MECHANISM-Elective

Identifier Type: -

Identifier Source: org_study_id