Long-term Clinical Outcomes in Patients With FFR Guided-Deferred Coronary Lesions, Assessed by IVUS Analysis (REFERRAL)

Long-term Clinical Outcomes in Patients With FFR GuidEd-DeFERred CoRonAry Lesions, Assessed by IVUS Analysis

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed Description

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.

1. Target patient screening The database will select patients who meet the selection and exclusion criteria.
2. target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record.
3. coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter.
4. intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).

• Study Type: Observational
• Enrollment (Actual): 459

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • KeimyungUniversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-oriented composite outcome	all-cause death, myocardial infarction and any revascularization	during 5-year

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2019-05-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No