NCT01414361

Brief Summary

Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR \< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2011

Enrollment Period

2.7 years

First QC Date

August 9, 2011

Last Update Submit

August 10, 2011

Conditions

Coronary Artery Stenosis

Keywords

Coronary artery stenosisFractional flow reserveIntravascular ultrasonography

Outcome Measures

Primary Outcomes (1)

  • lumen area

    lumen area cut-off that can predict functional significance of a lesion

    day 1

Secondary Outcomes (1)

  • angiographic stenosis, % plaque area

    day 1

Study Arms (1)

intermediate lesion

intermediate lesions evaluated by both IVUS and FFR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intermediate coronary stenosis who underwent both FFR and IVUS

You may qualify if:

  • Intermediate coronary stenosis by visual estimation

You may not qualify if:

  • history of coronary artery bypass graft surgery
  • previously revascularized lesion
  • creatinine \> 1.6 mg/dL or eGFR \< 30 ml/min/1.73m2 pre-procedure per institutional standards
  • known pregnancy
  • contrast agent allergy that cannot be adequately premedicated
  • severe PVD precluding cardiac catheterization
  • patient not a candidate for IVUS and FFR
  • inability or unwillingness to provide informed consent
  • inability or unwillingness to perform required follow up procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Bon-Kwon Koo, MD, PhD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Kwon Koo, MD/PhD

CONTACT

82-2-2072-2062bkkoo@snu.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

March 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

August 11, 2011

Record last verified: 2011-08

Locations

KR(1)