Clinical Trials Logo

Clinical Trial Summary

TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and has 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, with respect to the physiological indices measured by the Pressure Wire.


Clinical Trial Description

This study will evaluate the safety and efficacy of the fractional flow reserve (FFR) and constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, with respect to the FFR and resting full-cycle ratio (RFR) by the Pressure Wire. The diagnostic accuracy of FFR by the TruePhysio pressure microcatheter system is evaluated, using the FFR by the Pressure Wire system as reference. The diagnostic accuracy of the hybrid cRR-FFR scheme by the TruePhysio pressure microcatheter is evaluated, using its own FFR as reference; The diagnostic accuracy of the hybrid RFR-FFR scheme by the Pressure Wire system is evaluated, using its own FFR as reference. The hybrid scheme for cRR-FFR (pressure microcatheter system), or RFR-FFR (pressure wire system), is defined as following: - if cRR or RFR of the target vessel is <0.86, it is diagnosed as functionally positive in myocardial ischemia; - if cRR or RFR of the target vessel is >0.93, it is diagnosed as functionally negative in myocardial ischemia; - if cRR or RFR of the target vessel is between 0.86 and 0.93 (including 0.86 and 0.93), the diagnostic criterion is superseded by that of FFR, which is: - if FFR of the target vessel is > 0.80, it is diagnosed as functionally negative in myocardial ischemia; - if FFR of the target vessel is ≤ 0.80, it is diagnosed as functionally positive in myocardial ischemia. A total of 484 patients are anticipated to be recruited from 11 centers in China. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05417763
Study type Observational
Source Insight Lifetech Co., Ltd.
Contact Junbo Ge, MD
Phone +862164041990
Email [email protected]
Status Recruiting
Phase
Start date February 25, 2022
Completion date November 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Not yet recruiting NCT04647448 - Multisensor Array for the Localisation of Coronary Artery Stenosis (MALCAS)
Not yet recruiting NCT05030818 - Cross-over Study of Coronary Risk Factors With a Polypill Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Recruiting NCT04562805 - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Active, not recruiting NCT04483791 - DynamX Bioadaptor Hong Kong Registry Phase 4
Completed NCT04375085 - DESyne X2 Post Market Follow-up Study N/A