Prospective, Multicenter, Self-controlled Clinical Trial to Validate Optical Ultrasonic Flow Ratio (OUFR)

NCT06726252 | Completed

• 1 other identifier: Optical Ultrasonic Flow Ratio
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of is study is to validate a novel computational Fractional Flow Reserve (FFR) index method, termed Optical Ultrasonic Flow Ratio (OUFR), based on intravascular imaging including intravascular optical coherence tomography (OCT) and intravascular ultrasound (IVUS), using wire-based FFR as the gold standard. This is a prospective, multi-center, self-controlled clinical trial involving at least four medical centers and recruiting at least 114 subjects based on statistical power analysis. Participants undoing anticipated percutaneous coronary intervention will be performed:

1. 1.Wire-based FFR measurement
2. 2.Intravascular imaging, including IVUS and integrated OCT-IVUS using a single catheter.

Conditions

Fractional Flow Reserve; Coronary Artery Disease

Keywords

FFR; IVUS; OCT

Outcome Measures

Primary Outcomes (1)

• Patient-level sensitivity and specificity

  With wire-based FFR measurement as the gold standard, using FFR=0.8 as the diagnostic threshold (FFR≤0.8: positive, FFR\>0.8: negative), evaluate patient-level sensitivity, specificity of (1) OUFR computed based on OCT (OUFRo); (2) OUFR based on IVUS (OUFRi); and (3) OUFR based on both OCT and IVUS (OUFRoi).

  "From enrollment to the end of data analysis, up to 12 months

Secondary Outcomes (3)

• Vessel-level sensitivity and specificity of OUFR

  "From enrollment to the end of data analysis, up to 12 months

• Patient-level accuracy of OUFR

  From enrollment to the end of data analysis, up to 12 months

• Patient and vessel level positive predictive value (PPV), negative predictive value (NPV) and area under the ROC curve (AUC)

  From enrollment to the end of data analysis, up to 12 months

Study Arms (1)

Validation of OUFR using wire-based FFR measurement as the gold standard

EXPERIMENTAL

Participants undoing anticipated percutaneous coronary intervention will be performed wire-based FFR measurement and intravascular imaging, including IVUS and integrated OCT-IVUS using a single catheter, to assess the sensitivity, specificity and oter performance measures of OUFR, using wire-based FFR as the gold standard.

Device: FFR measurement and intravascular imaging

Interventions

FFR measurement and intravascular imaging DEVICE

Participants undoing anticipated percutaneous coronary intervention will be performed wire-based FFR measurement, and intravascular imaging, including IVUS and integrated OCT-IVUS using a single cathete to assess the accurary of OUFR, using wire-based FFR measurement as the gold standard.

Validation of OUFR using wire-based FFR measurement as the gold standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Anticipate to be performed percutaneous coronary intervention (PCI)
• Can sustain FFR measurement, IVUS and OCT imaging
• Understand the objective of this study, and sign informed consent form voluntarily
• The pullback of intravascular imaging covers the FFR measurement site and the entire stenotic lesion, and the OCT and IVUS images are of sufficient quality for OUFR analysis

You may not qualify if:

• Women with pregnancy or anticipate to be pregnant within 6 months
• Participated in other clinical studies within 3 months
• Had acute coronary syndromes within 30 days
• Heart failure (NYHA III or NYHA IV, or left ventricular ejection fraction\<30%)
• Abnormal levels of cTnI or cTnT within 72 hours of the procedure
• Had coronary artery bypass grafting surgery
• Diagnosed as bacteremia or septicemia
• Diagnosed as coronary artery spasm
• Clinically significant abnormal coagulation function
• Clinically significant abnormal liver or kidney function
• Clinically significant hemodynamic disorders or coma
• Allergic to contrast or have other potential risks due to allergy
• Presence of clinical unstable conditions, including acute chest pain, cardiogenic shock, unstable blood pressure (e.g. systolic pressure \< 90mmHg), severe congestive heart failure or acute pulmonary edema
• Presence of other medical conditions not suitable for participating in this clinical study, such as complex congenital heart disease, myocardial bridge, long QT syndrome (LQTS), severe asthma, severe chronic obstructive pulmonary disease (COPD), or COPD with a dependency on bronchodilator, or with other severe infection or acute diseases
• Reference vessel diameter outside the range of 2.0-4.0mm by angiography, and diameter stenosis outside the range of 30%-90%

Sponsors & Collaborators

• Harbin Medical University: lead
• Peking University Third Hospital: collaborator
• Panovision: collaborator
• Capital Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Jining Medical University: collaborator
• Peking University First Hospital: collaborator

Study Sites (5)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Beijing Luhe Hospital Capital Medical University

Beijing, Beijing Municipality, 101100, China

Location

Harbin Medical University

Harbin, Heilongjiang, 163711, China

Location

Jining Medical University

Jining, Shandong, 272067, China

Location

Related Publications (3)

• Huang J, Emori H, Ding D, Kubo T, Yu W, Huang P, Zhang S, Gutierrez-Chico JL, Akasaka T, Wijns W, Tu S. Diagnostic performance of intracoronary optical coherence tomography-based versus angiography-based fractional flow reserve for the evaluation of coronary lesions. EuroIntervention. 2020 Sep 18;16(7):568-576. doi: 10.4244/EIJ-D-19-01034.

  PMID: 31951207 BACKGROUND

• Jia H, Zhao C, Yu H, Wang Z, Liu H, Xu M, Hu S, Li L, He L, Weng Z, Qin Y, Xu Y, Zeng M, Su X, Liu B, Hou J, Yu B. Clinical performance of a novel hybrid IVUS-OCT system: a multicentre, randomised, non-inferiority trial (PANOVISION). EuroIntervention. 2023 Jul 17;19(4):e318-e320. doi: 10.4244/EIJ-D-22-01058. No abstract available.

  PMID: 37057604 BACKGROUND

• Yu W, Huang J, Jia D, Chen S, Raffel OC, Ding D, Tian F, Kan J, Zhang S, Yan F, Chen Y, Bezerra HG, Wijns W, Tu S. Diagnostic accuracy of intracoronary optical coherence tomography-derived fractional flow reserve for assessment of coronary stenosis severity. EuroIntervention. 2019 Jun 20;15(2):189-197. doi: 10.4244/EIJ-D-19-00182.

  PMID: 31147309 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bo Yu, MD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, cardiology department, the 2nd Affiliated Hospital of Harbin Medical University

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 10, 2024
• Study Start: November 10, 2024
• Primary Completion: April 7, 2025
• Study Completion: June 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)