Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Fractional Flow Reserve and Intravascular Ultrasound

NCT01133015

Coronary Artery Stenosis

UNKNOWN PHASE4

Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis

NCT02673424

Stable Angina

ACTIVE_NOT_RECRUITING NA

Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions

NCT06052670

Coronary Artery Stenosis

UNKNOWN

VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

NCT01444599

Coronary Disease

COMPLETED

Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis

NCT06053944

Left Main Coronary Artery Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators 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 the our 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intermediate lesion

intermediate lesions evaluated by both IVUS and FFR

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Intermediate coronary stenosis by visual estimation

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No