NCT06726252Completed
Prospective, Multicenter, Self-controlled Clinical Trial to Validate Optical Ultrasonic Flow Ratio (OUFR)
A Prospective, Multicenter, Self-controlled Clinical Trial to Validate Optical Ultrasonic Flow Ratio (OUFR) Based on Intravascular Imaging
Source: ClinicalTrials.gov · Last updated 15 Jul 2025
Brief summary (registry, in English)
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. Wire-based FFR measurement 2. Intravascular imaging, including IVUS and integrated OCT-IVUS using a single catheter. The primary endpoint is to assess patient-level sensitivity, specificity of OUFR computed based on OCT; (2) OUFR based on IVUS, and OUFR based on both OCT and IVUS, using wire-based FFR measurement as the gold standard.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 12 Nov 2024
- Start date
- 10 Nov 2024
- Primary completion date
- 7 Apr 2025
- Lead sponsor
- Harbin Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT06726252
What you commit to
- Study type: Interventional
- Participants enrolled: 114
- From 10 Nov 2024 to the primary completion date, 7 Apr 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had coronary artery bypass grafting surgery
- Target vessel with previous stenting
Other illness
- Had acute coronary syndromes within 30 days
- 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
- Unable to observe maximal hyperemia during FFR measurement or failure to obtain FFR data
Lab values
- Heart failure (NYHA III or NYHA IV, or left ventricular ejection fraction\<30%)
- 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
- Intravascular imaging failure due to the damage of imaging catheters or insufficient blood clearance, or operational factors
Other
- Women with pregnancy or anticipate to be pregnant within 6 months
- Participated in other clinical studies within 3 months
- Abnormal levels of cTnI or cTnT within 72 hours of the procedure
- Diagnosed as bacteremia or septicemia
- Diagnosed as coronary artery spasm
- Clinically significant abnormal coagulation function
- Clinically significant abnormal liver or kidney function
- Reference vessel diameter outside the range of 2.0-4.0mm by angiography, and diameter stenosis outside the range of 30%-90%
- Lesions associated with left main or coronary ostium, target vessel with severe tortuosity or calcified lesions, coronary total occlusion, diffuse lesions
- Target vessel with thrombus or dissection confirmed by angiography
- Target vessel with the minimum lumen diameter \< 1.1mm
- TIMI flow grade≤2
- Balloon predilatation before FFR wire measurement or intravascular imaging
- FFR wire or intravascular imaging catheter cannot pass the stenotic lesion
- Presence of vasospasm or injury during imaging
- Other reasons identified by investigators that preclude the subjects from participating in the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Luhe Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.