NCT01175863

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

4.2 years

First QC Date

August 3, 2010

Last Update Submit

February 11, 2014

Conditions

Coronary Artery Stenosis

Keywords

intravascular ultrasoundfractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)

    1 year

Secondary Outcomes (13)

  • Cardiac death

    1 and 2 years

  • Myocardial infarction (MI)

    1 and 2 years

  • Composite of cardiac death or myocardial infarction

    1 and 2 years

  • Target vessel revascularization (ischemia- and clinically-driven)

    1 and 2 years

  • Target lesion revascularization (ischemia- and clinically-driven)

    1 and 2 years

  • +8 more secondary outcomes

Study Arms (2)

Intravascular ultrasound

ACTIVE COMPARATOR
Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)

Fractional flow reserve

ACTIVE COMPARATOR
Device: Pressure wire(Radi Medical Systems)

Interventions

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

minimal lumen area on Intravascular ultrasound

Also known as: Galaxy (Boston Scientific), Virtual histology (Volcano)
Intravascular ultrasound
Pressure wire(Radi Medical Systems)DEVICE

Fractional flow reserve measured by pressure wire

Also known as: Pressure wire (Radi Medical Systems)
Fractional flow reserve

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Keimyung university Dongsan medical center

Daegu, South Korea

Location

Inje University

Ilsan, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul national university hospital

Seoul, South Korea

Location

Yensei University Gangnam Severance Hospital

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, South Korea

Location

Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Sejung-Jea Tahk, MD, PhD

    Ajou University Medical Center, Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

KR(8)