NCT00351780

Brief Summary

Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy Method: Provisional side branch intervention if jailed side branch FFR\<0.75

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2004

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

3.5 years

First QC Date

July 12, 2006

Last Update Submit

July 15, 2011

Conditions

Coronary Artery Disease

Keywords

fractional flow reservebifurcationstent

Interventions

FFR measurement, side branch angioplastyDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Jailed side branches with an ostial stenosis \>50%, vessel size \>2mm, vessel length \>40mm and lesion length \<10mm by visual estimation.

You may not qualify if:

  • ST elevation myocardial infarction Left main stenosis, totally occluded lesion Angiographically visible thrombus, significant lesion within the main branch proximal to the stented segment, significant distal lesion at a side branch Regional wall motion abnormalities of the stented artery and jailed side branch segments Left ventricular ejection fraction\<40% Primary myocardial disease Serum creatinine \>2mg/dl Predilatation of side branch before the main branch stent implantation Contraindications to adenosine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-799, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bon-Kwon Koo, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 13, 2006

Study Start

June 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

KR(1)