Last reviewed · How we verify
NCT05417763: SUPREME II
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
trial testing Randomized physiological measurements by the two systems in Coronary Artery Disease in 487 participants. Completed in 1 December 2022.
16 July 2022
Quick facts
| Lead sponsor | Insight Lifetech Co., Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 487 |
| Start date | 28 February 2022 |
| Primary completion | 16 July 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 11 locations across China |
Drugs / interventions tested
- Randomized physiological measurements by the two systems
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Coronary Disease — all drugs for Coronary Disease →
- Myocardial Ischemia — all drugs for Myocardial Ischemia →
Sponsor
Insight Lifetech Co., Ltd.
Who can join
18 and older, any sex, with Coronary Artery Disease or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME study (NCT03541577). This study will further evaluate the safety and efficacy of the physiological indices measured by the TruePhysio pressure microcatheter, including resting and hyperemic indices, with respect to the physiological indices measured by the Pressure Wire.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical Validation of a Novel Pressure Microcatheter-Based Nonhyperemic Pressure Ratio (SUPREME II Study).
Zhou J, Yang J, Zhang W, Zu L, et al · · 2026 · PMID 41823250 · DOI 10.1161/jaha.125.041920 -
Functional assessment of coronary stenosis: alternative hyperemic, nonhyperemic, and angiographic indexes.
Vergni F, Fiore G, Pellone F, Luzi M. · · 2024 · PMID 40415782 · DOI 10.24875/recice.m24000444
Verify or expand the search:
- PubMed search for NCT05417763
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Insight Lifetech Co., Ltd. trials
Trials by the same sponsor.
- NCT07176585 — A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Pl · completed
- NCT06030271 — A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross · NA · completed
- NCT04739657 — Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System · completed
- NCT03541577 — Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement · 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 NCT05417763 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insight Lifetech Co., Ltd.
- Last refreshed: 20 December 2023
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/NCT05417763.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing