Trial Outcomes & Findings for Functional ComprEhensive AssessmenT by IVUS Reconstruction in Patients With Suspected IschEmic Heart Disease (FEATURE) (NCT NCT05694065)

NCT ID: NCT05694065

Last Updated: 2025-11-24

Results Overview

UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Target enrollment: 112 participants
• Primary outcome timeframe: baseline
• Results posted on: 2025-11-24

Participant Flow

Participant milestones

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease Onsite Ultrasonic Flow Ratio (UFR) and Fractional Flow Reserve (FFR) Assessment in Patients with Suspected Ischemic Heart Disease
Overall Study STARTED	112
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease Onsite Ultrasonic Flow Ratio (UFR) and Fractional Flow Reserve (FFR) Assessment in Patients with Suspected Ischemic Heart Disease
Overall Study Intravascular ultrasound (IVUS) pullback fails to cover the complete target lesion	3
Overall Study Ineligible for diagnostic intervention (IVUS or FFR examination)	2
Overall Study Target vessel with severe myocardial bridge	1

Baseline Characteristics

Six participants were excluded according to the predefined exclusion criteria.

Baseline characteristics by cohort

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease n=106 Participants Onsite UFR and FFR Assessment in Patients with Suspected Ischemic Heart Disease
Age, Continuous	68.5 years n=106 Participants • Six participants were excluded according to the predefined exclusion criteria.
Sex: Female, Male Female	30 Participants n=106 Participants • Six participants were excluded according to the predefined exclusion criteria.
Sex: Female, Male Male	76 Participants n=106 Participants • Six participants were excluded according to the predefined exclusion criteria.
Body Mass Index (BMI)	24.6 Kg/m^2 STANDARD_DEVIATION 3.2 • n=106 Participants • Six participants were excluded according to the predefined exclusion criteria.

PRIMARY outcome

Timeframe: baseline

Population: Six participants were excluded according to the predefined exclusion criteria.

UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis.

The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.

Outcome measures

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease n=106 Participants FFR and UFR were assessed onsite in the catheterization laboratory for patients with suspected ischemic heart disease.
Diagnostic Accuracy of Onsite UFR	94 percentage of correctly classified cases Interval 88.0 to 97.0

SECONDARY outcome

Timeframe: baseline

Population: Six participants were excluded according to the predefined exclusion criteria.

The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.

Sensitivity was defined as the percentage of true positives correctly identified by UFR.

Outcome measures

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease n=106 Participants FFR and UFR were assessed onsite in the catheterization laboratory for patients with suspected ischemic heart disease.
Sensitivity of Onsite UFR	88 percentage of true positives Interval 75.0 to 96.0

SECONDARY outcome

Timeframe: baseline

Population: Six participants were excluded according to the predefined exclusion criteria.

The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.

Specificity was defined as the percentage of true negatives correctly identified by UFR.

Outcome measures

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease n=106 Participants FFR and UFR were assessed onsite in the catheterization laboratory for patients with suspected ischemic heart disease.
Specificity of Onsite UFR	97 percentage of true negatives Interval 90.0 to 99.0

SECONDARY outcome

Timeframe: baseline

Population: Six participants were excluded according to the predefined exclusion criteria.

The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.

Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value.

Outcome measures

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease n=106 Participants FFR and UFR were assessed onsite in the catheterization laboratory for patients with suspected ischemic heart disease.
Sensitivity of Minimal Lumen Area (MLA)	47 percentage of true positives Interval 31.0 to 62.0

SECONDARY outcome

Timeframe: baseline

Population: Six participants were excluded according to the predefined exclusion criteria.

The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.

Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value.

Outcome measures

Measure	Functional Assessment in Patients With Suspected Ischemic Heart Disease n=106 Participants FFR and UFR were assessed onsite in the catheterization laboratory for patients with suspected ischemic heart disease.
Specificity of MLA	84 percentage of true negatives Interval 75.0 to 91.0

Adverse Events

Functional Assessment in Patients With Suspected Ischemic Heart Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fenghua Ding

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Phone: +00 86 21 64370045

Email: ruijindfh@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place