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OpenTrials
Completed

NCT Number: NCT04068779

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KeimyungUniversity

Daegu, 42601, South Korea

About this study

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.

  • Target patient screening The database will select patients who meet the selection and exclusion criteria.
  • 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.
  • 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.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Primary outcomes

  1. patient-oriented composite outcome

    Time frame: during 5-year

    all-cause death, myocardial infarction and any revascularization

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Acronym: REFERRAL

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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