SUPREME II: Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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if cRR or RFR of the target vessel is between 0.86 and 0.93 (including 0.86 and 0.93), the diagnostic criterion is superseded by that of FFR, which is: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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pressure Microcatheter-First Per the result of prior randomization, physiological assessment to the enrolled patient will be performed by the TruePhysio pressure microcatheter system ahead of the Pressure Wire system. |
Device: Randomized physiological measurements by the two systems
To measure physiological indices (FFR, cRR and RFR), either pressure microcatheter or pressure wire enters one patient's body. Whether it is the pressure microcatheter or pressure wire firstly to enter is randomized. After completion of one system's physiological assessment, the other system will follow for its physiological assessment.
|
| Pressure Wire-First Per the result of prior randomization, physiological assessment to the enrolled patient will be performed by the Pressure Wire system ahead of the TruePhysio pressure microcatheter system, per the result of prior randomization. |
Device: Randomized physiological measurements by the two systems
To measure physiological indices (FFR, cRR and RFR), either pressure microcatheter or pressure wire enters one patient's body. Whether it is the pressure microcatheter or pressure wire firstly to enter is randomized. After completion of one system's physiological assessment, the other system will follow for its physiological assessment.
|
Outcome Measures
Primary Outcome Measures
- The accuracy, sensitivity and specificity of FFR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by Pressure Wire as the reference
- The accuracy, sensitivity and specificity of the hybrid cRR-FFR scheme, concluded by TruePhysio pressure microcatheter, in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by TruePhysio pressure microcatheter as the reference
Secondary Outcome Measures
- The positive and negative predictive values of FFR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by Pressure Wire as the reference
- The area under the Receiver Operating Characteristic (ROC) curve (AUC) of FFR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by Pressure Wire as the reference
- Results of Passing-Bablok regression analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire [Immediate upon completion of the procedure for the last enrolled patient]
Paired FFR values by the two systems are analyzed by Passing-Bablok regression
- Results of Pearson correlation between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire [Immediate upon completion of the procedure for the last enrolled patient]
Paired FFR values by the two systems are analyzed by Pearson correlation
- Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire as assessed by Bland-Altman analysis [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by Pressure Wire as the reference
- The overall positive and negative predictive values of the cRR-FFR hybrid scheme, concluded by TruePhysio pressure microcatheter, in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by the TruePhysio pressure microcatheter as the reference
- When the cRR value is <0.86 or >0.93, the cRR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by the TruePhysio pressure microcatheter as the reference
- The proportion of the subcohort, whose cRR value is <0.86 or >0.93, to the entire cohort [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by the TruePhysio pressure microcatheter as the reference. Each enrolled patient only has one vessel to be physiologically assessed.
- The overall accuracy, sensitivity, specificity, positive and negative predictive values of the RFR-FFR hybrid scheme, concluded by Pressure Wire, in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by the Pressure Wire as the reference
- When RFR is <0.86 or >0.93, the RFR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by the Pressure Wire as the reference.
- The proportion of the subcohort, whose RFR value is <0.86 or >0.93, to the entire cohort [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by the Pressure Wire as the reference. Each enrolled patient only has one vessel to be physiologically assessed.
- Results of Passing-Bablok regression analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire [Immediate upon completion of the procedure for the last enrolled patient]
Paired cRR-RFR values by the two systems are analyzed in Passing-Bablok regression
- Results of Bland-Altman analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire [Immediate upon completion of the procedure for the last enrolled patient]
Paired cRR-RFR values by the two systems are analyzed in Bland-Altman analysis
- Results of Pearson's correlation between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire [Immediate upon completion of the procedure for the last enrolled patient]
Paired cRR-RFR values by the two systems are analyzed in Pearson correlation
- The overall accuracy, sensitivity, specificity, positive and negative predictive values of cRR in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by TruePhysio pressure microcatheter as the reference
- The overall accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RFR in diagnosing myocardial ischemia [Immediate upon completion of the procedure for the last enrolled patient]
Using FFR measured by Pressure Wire as the reference
- Rate of clinically significant drift [Immediate upon completion of the procedure for the last enrolled patient]
Drift is defined as the difference between FFR value and 1 when pressure sensor is pulled back to coronary artery ostium for verification. Clinically significant drift occurs when the device has a drift with absolute value > 0.03; alternatively, drift is regarded as clinically significant when the Pd/Pa at the ostium for verification is either <0.97 or >1.03. Clinically significant drift is recorded per appearance, regardless whether the measurement is eventually successful or not. Its rate is calculated as: Times of clinically significant drift occurred in total / Times of measuring attempted in total
- Rate of device success [Immediate upon completion of the procedure for the last enrolled patient]
Device success is defined when a device successfully crossed the lesion and completed acquisition of valid physiological values. For any vessel, if valid cRR and FFR values by the TruePhysio pressure microcatheter are acquired, the measurement of TruePhysio pressure microcatheter is successful in the specific vessel, disregarding how many times it was attempted; For any vessel, if valid RFR and FFR values by the Pressure Wire are acquired, the measurement of Pressure Wire is successful in the specific vessel, disregarding how many times it was attempted. Rate of device success is calculated as: Vessels with device success / Total vessels
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 18 years old;
-
Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
-
Clinically indicated to physiological assessment.
Exclusion Criteria:
-
Unable to comprehend, or unwilling to sign the informed consent form;
-
Contraindicated to the procedures of invasive coronary angiography or percutaneous coronary intervention;
-
Clinically diagnosed with severe coronary artery vasospasm;
-
Other operator-discerned facts that will make enrollment or the procedure impossible to complete.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijing | Beijing | China | |
| 2 | First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing | China | |
| 3 | Xiamen Cardiovascular Hospital, Xiamen University | Xiamen | Fujian | China | |
| 4 | Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | |
| 5 | Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | China | |
| 6 | First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | |
| 7 | Shandong Provincial Hospital | Jinan | Shandong | China | |
| 8 | Shanghai Zhongshan Hospital | Shanghai | Shanghai | China | |
| 9 | First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China | |
| 10 | Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China | |
| 11 | First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
Sponsors and Collaborators
- Insight Lifetech Co., Ltd.
- Shanghai Zhongshan Hospital
- Guangdong Provincial People's Hospital
- Peking University Third Hospital
- First Affiliated Hospital of Harbin Medical University
- Sir Run Run Shaw Hospital
- Shandong Provincial Hospital
- Zunyi Medical College
- Xiamen Cardiovascular Hospital, Xiamen University
- First Affiliated Hospital of Xinjiang Medical University
- First Affiliated Hospital of Wenzhou Medical University
- First Affiliated Hospital of Chongqing Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTP-01-001