Last reviewed · How we verify
NCT06726252: OUFR
Prospective, Multicenter, Self-controlled Clinical Trial to Validate Optical Ultrasonic Flow Ratio (OUFR)
NA trial testing FFR measurement and intravascular imaging in Fractional Flow Reserve in 114 participants. Completed in 30 June 2025.
7 April 2025
Quick facts
| Lead sponsor | Harbin Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 114 |
| Start date | 10 November 2024 |
| Primary completion | 7 April 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 5 locations across China |
Drugs / interventions tested
- FFR measurement and intravascular imaging
Conditions studied
- Fractional Flow Reserve — all drugs for Fractional Flow Reserve →
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Harbin Medical University
Who can join
18 and older, any sex, with Fractional Flow Reserve or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06726252
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fractional Flow Reserve
Currently open trials in the same condition.
- NCT06659367 — Dedinje FFR/QFR Registry · recruiting
Other Harbin Medical University trials
Trials by the same sponsor.
- NCT07471815 — Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mecha · Phase 2 · active not recruiting
- NCT07187674 — The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonr · NA · not yet recruiting
- NCT07161791 — Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07033624 — Cardiovascular Risk Early Screening and Warning in Harbin : A Prospective Cohort Study · not yet recruiting
- NCT06947148 — The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06726252 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harbin Medical University
- Last refreshed: 15 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06726252.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing