Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease

NCT ID: NCT01175863

Last Updated: 2014-02-12

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

PHASE4

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-05-31

Brief Summary

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This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.

Detailed Description

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This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.

Conditions

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Coronary Artery Stenosis

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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Intravascular ultrasound

Group Type ACTIVE_COMPARATOR

Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)

Intervention Type DEVICE

minimal lumen area on Intravascular ultrasound

Fractional flow reserve

Group Type ACTIVE_COMPARATOR

Pressure wire(Radi Medical Systems)

Intervention Type DEVICE

Fractional flow reserve measured by pressure wire

Interventions

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Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)

minimal lumen area on Intravascular ultrasound

Intervention Type DEVICE

Pressure wire(Radi Medical Systems)

Fractional flow reserve measured by pressure wire

Intervention Type DEVICE

Other Intervention Names

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Galaxy (Boston Scientific) Virtual histology (Volcano) Pressure wire (Radi Medical Systems)

Eligibility Criteria

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Inclusion Criteria

Clinical indication:

* Patients with angina or patients with documented silent ischemia
* Patients who are eligible for intracoronary stenting
* Age \> 18 years old, \< 75 years old

Angiographic indication:

* Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation
* Reference vessel diameter ≥ 3.0mm by visual estimation

Exclusion Criteria

* Acute or old myocardial infarction
* Previous coronary artery bypass graft
* Left main disease (≥ 50% stenosis)
* In-stent restenosis lesion
* Chronic total occlusion
* Low ejection fraction (\< 40 %)
* Graft vessel lesion
* History of bleeding diathesis or coagulopathy
* Limited life-expectancy (less than 1 year) due to combined serious disease
* Contra-indication to heparin, everolimus
* Contraindication to aspirin, clopidogrel or cilostazol
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jea Tahk

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sejung-Jea Tahk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University Medical Center, Ajou University School of Medicine

Locations

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Keimyung university Dongsan medical center

Daegu, , South Korea

Site Status

Inje University

Ilsan, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Seoul national university hospital

Seoul, , South Korea

Site Status

Yensei University Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Ajou University Medical Center

Suwon, , South Korea

Site Status

Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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FAVOR

Identifier Type: -

Identifier Source: org_study_id

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