NCT04068779

Brief Summary

This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

May 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

September 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

August 23, 2019

Last Update Submit

September 1, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • patient-oriented composite outcome

    all-cause death, myocardial infarction and any revascularization

    during 5-year

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.

You may qualify if:

  • Subject over 19 years old
  • Patients with mild or moderate stenosis lesions on coronary angiography
  • Patients with lesions with FFR values greater than 0.80
  • Patients with analytical intravascular ultrasound images

You may not qualify if:

  • Left main lesion
  • History of coronary artery bypass grafting
  • Patients with lower left ventricular ejection fraction (\<25%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KeimyungUniversity

Daegu, 42601, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

May 31, 2019

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

September 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)