Coronary Artery DiseaseSUPREME IINCT05417763
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
An observational study of Coronary Artery Disease and Coronary Disease, run by Insight Lifetech Co., Ltd. at 11 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- What is being tested?
- Randomized physiological measurements by the two systems
- Type of treatment
- Medical device
- How many people
- 487 participants
- Where
- 11 sitesChina
- Study dates
- 28 Feb 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with coronary artery disease.
Who may be able to join
- At least 18 years old;
- Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
- Clinically indicated to physiological assessment.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Peking University Third Hospital
Beijing, Beijing Municipality
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Shandong Provincial Hospital
Jinan, Shandong
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: Pressure Microcatheter for Physiological Measurements - A Prospective, Multicenter, Randomized Study
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.
Read the detailed description
This study will evaluate the safety and efficacy of the constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, in both binary and hybrid strategy, with respect to its own fractional flow reserve (FFR) and the FFR or resting full-cycle ratio (RFR) by the Pressure Wire. And the safety and efficacy of the FFR measured by the TruePhysio pressure microcatheter in patients with a border range of diameter stenosis also be validated with respect to the FFR by the Pressure Wire.
The diagnostic accuracy of cRR by the TruePhysio pressure microcatheter system is evaluated, using FFR measured by both systems as reference;
Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire is evaluated, using FFR measured by Pressure Wire as the 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:
- the gray zone is defined as where the sensitivity and specificity are equal, shown as [A, B].
- if cRR or RFR of the target vessel is <A, it is diagnosed as functionally positive in myocardial ischemia;
- if cRR or RFR of the target vessel is >B, it is diagnosed as functionally negative in myocardial ischemia;
- if cRR or RFR of the target vessel is between A and B (including A and B), 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 487 patients are anticipated to be recruited from 11 centers in China.
- Being tested
- Randomized physiological measurements by the two systems
- Keywords
- fractional flow reserve, constant-resistance ratio, resting full-cycle ratio
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized physiological measurements by the two systemsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Randomized physiological measurements by the two systems | |
| 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. Receives: Device: Randomized physiological measurements by the two systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Using FFR measured by TruePhysio pressure microcatheter as the reference. The optimal binary cutoff for cRR is determined by using Youden's index.
Measured: Immediate upon completion of the procedure for the last enrolled patient
Secondary outcomes (25)
The area under the Receiver Operating Characteristic (ROC) curve (AUC) of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Using FFR measured by TruePhysio pressure microcatheter as the reference
Measured: Immediate upon completion of the procedure for the last enrolled patient
The sensitivity, specificity, positive and negative predictive values of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Using FFR measured by TruePhysio pressure microcatheter as the reference. The optimal binary cutoff for cRR is determined by using Youden's index.
Measured: Immediate upon completion of the procedure for the last enrolled patient
The AUC of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Using FFR measured by Pressure Wire as the reference
Measured: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive and negative predictive values of cRR in diagnosing myocardial ischemia
Using FFR measured by Pressure Wire as the reference. The optimal binary cutoff for cRR is determined by using Youden's index.
Measured: Immediate upon completion of the procedure for the last enrolled patient
The AUC of RFR measured by the Pressure Wire in diagnosing myocardial ischemia
Using FFR measured by Pressure Wire as the reference
Measured: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RFR in diagnosing myocardial ischemia
Using FFR measured by Pressure Wire as the reference. The binary cutoff for RFR is determined by previous study as 0.89.
Measured: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid cRR-FFR scheme, concluded by TruePhysio pressure microcatheter, in diagnosing myocardial ischemia
Using FFR measured by the TruePhysio pressure microcatheter as the reference. The gray zone is defined as where the false positive and negative ratios are equal.
Measured: Immediate upon completion of the procedure for the last enrolled patient
The proportion of the subcohort, whose cRR value is in the gray zone of the hybrid cRR-FFR scheme, to the entire cohort
Using FFR measured by the TruePhysio pressure microcatheter as the reference. Each enrolled patient only has one vessel to be physiologically assessed.
Measured: Immediate upon completion of the procedure for the last enrolled patient
When the cRR value is out of the gray zone of the hybrid cRR-FFR scheme, the cRR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia
Using FFR measured by the TruePhysio pressure microcatheter as the reference
Measured: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid RFR-FFR scheme, concluded by Pressure Wire, in diagnosing myocardial ischemia
Using FFR measured by the Pressure Wire as the reference. The gray zone is determined by previous study as [0.86, 0.93].
Measured: Immediate upon completion of the procedure for the last enrolled patient
The proportion of the subcohort, whose RFR value is in the gray zone of the hybrid RFR-FFR scheme, to the entire cohort
Using FFR measured by the Pressure Wire as the reference. Each enrolled patient only has one vessel to be physiologically assessed.
Measured: Immediate upon completion of the procedure for the last enrolled patient
When the RFR value is out of the gray zone of the hybrid RFR-FFR scheme, the RFR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia
Using FFR measured by the Pressure Wire as the reference
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson correlation between the cRR and FFR measured by TruePhysio pressure microcatheter
Paired values are analyzed by Pearson correlation
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between the cRR and FFR measured by TruePhysio pressure microcatheter
Paired values are analyzed by Passing-Bablok regression
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson correlation between the RFR and FFR measured by Pressure Wire
Paired values are analyzed by Pearson correlation
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between RFR and FFR measured by Pressure Wire
Paired values are analyzed by Passing-Bablok regression
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
Paired cRR-RFR values by the two systems are analyzed in Passing-Bablok regression
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Bland-Altman analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
Paired cRR-RFR values by the two systems are analyzed in Bland-Altman analysis
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson's correlation between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
Paired cRR-RFR values by the two systems are analyzed in Pearson correlation
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson correlation between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire
Paired FFR values by the two systems are analyzed by Pearson correlation
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire
Paired FFR values by the two systems are analyzed by Passing-Bablok regression
Measured: Immediate upon completion of the procedure for the last enrolled patient
Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire as assessed by Bland-Altman analysis
Using FFR measured by Pressure Wire as the reference
Measured: Immediate upon completion of the procedure for the last enrolled patient
Results of Bland-Altman analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire among the patients with atrial fibrillation or in severe stenosis or with small vessels
Using FFR measured by Pressure Wire as the reference. The severe stenosis is defined as the diameter stenosis higher than 70%, while the small vessel is defined as the reference vessel diameter smaller than 2.5 mm.
Measured: Immediate upon completion of the procedure for the last enrolled patient
Rate of significant drift
Drift is defined as the difference between FFR value and 1 when pressure sensor is pulled back to coronary artery ostium for verification.
Significant drift occurs when the device has a drift with absolute value > 0.03; alternatively, drift is regarded as significant when the Pd/Pa at the ostium for verification is either <0.97 or >1.03.
Significant drift is recorded per appearance, regardless whether the measurement is eventually successful or not. Its rate is calculated as:
Times of significant drift occurred in total / Times of measuring attempted in total
Measured: Immediate upon completion of the procedure for the last enrolled patient
Rate of device success
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
Measured: Immediate upon completion of the procedure for the last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start28 Feb 2022
- Primary completion16 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Lifetech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417763
- Sponsor's protocol ID
- CTP-01-001
- Acronym
- SUPREME II
- Status last verified
- Dec 2023
- First submitted
- 7 Jun 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou J, Yang J, Zhang W, Zu L, Cheng Y, Li M, Ma K, Zhou H, Ma X, Yuan H, Wang Y, Fu G, Li Y, Tang Y, Shi B, Gori T, Qian J, Chen J, Li C, Ge J; SUPREME II Study Investigators. Clinical Validation of a Novel Pressure Microcatheter-Based Nonhyperemic Pressure Ratio (SUPREME II Study). J Am Heart Assoc. 2026 Mar 17;15(6):e041920. doi: 10.1161/JAHA.125.041920. Epub 2026 Mar 13.
PubMed 41823250
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Microcatheter for Physiological Measurements - A Prospective, Multicenter, Randomized Study
- ClinicalTrials.gov ID
- NCT05417763
- Acronym / sponsor ID
- SUPREME II / CTP-01-001
- Keywords
- fractional flow reserve, constant-resistance ratio, resting full-cycle ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Insight Lifetech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- 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
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 16 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will evaluate the safety and efficacy of the constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, in both binary and hybrid strategy, with respect to its own fractional flow reserve (FFR) and the FFR or resting full-cycle ratio (RFR) by the Pressure Wire. And the safety and efficacy of the FFR measured by the TruePhysio pressure microcatheter in patients with a border range of diameter stenosis also be validated with respect to the FFR by the Pressure Wire.
The diagnostic accuracy of cRR by the TruePhysio pressure microcatheter system is evaluated, using FFR measured by both systems as reference;
Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire is evaluated, using FFR measured by Pressure Wire as the 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:
- the gray zone is defined as where the sensitivity and specificity are equal, shown as [A, B].
- if cRR or RFR of the target vessel is <A, it is diagnosed as functionally positive in myocardial ischemia;
- if cRR or RFR of the target vessel is >B, it is diagnosed as functionally negative in myocardial ischemia;
- if cRR or RFR of the target vessel is between A and B (including A and B), 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 487 patients are anticipated to be recruited from 11 centers in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Microcatheter-First | – | Device: Randomized physiological measurements by the two systemsPer 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. |
| Pressure Wire-First | – | Device: Randomized physiological measurements by the two systemsPer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with coronary artery disease.
Key inclusion criteria (3 listed)
- At least 18 years old;
- Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
- Clinically indicated to physiological assessment.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized physiological measurements by the two systemsTo 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. | Device | Pressure Microcatheter-First, Pressure Wire-First |
Primary outcome
The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Using FFR measured by TruePhysio pressure microcatheter as the reference. The optimal binary cutoff for cRR is determined by using Youden's index.
25 secondary outcomes
The area under the Receiver Operating Characteristic (ROC) curve (AUC) of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The sensitivity, specificity, positive and negative predictive values of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The AUC of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive and negative predictive values of cRR in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The AUC of RFR measured by the Pressure Wire in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RFR in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid cRR-FFR scheme, concluded by TruePhysio pressure microcatheter, in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The proportion of the subcohort, whose cRR value is in the gray zone of the hybrid cRR-FFR scheme, to the entire cohort
Time frame: Immediate upon completion of the procedure for the last enrolled patient
When the cRR value is out of the gray zone of the hybrid cRR-FFR scheme, the cRR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid RFR-FFR scheme, concluded by Pressure Wire, in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
The proportion of the subcohort, whose RFR value is in the gray zone of the hybrid RFR-FFR scheme, to the entire cohort
Time frame: Immediate upon completion of the procedure for the last enrolled patient
When the RFR value is out of the gray zone of the hybrid RFR-FFR scheme, the RFR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson correlation between the cRR and FFR measured by TruePhysio pressure microcatheter
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between the cRR and FFR measured by TruePhysio pressure microcatheter
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson correlation between the RFR and FFR measured by Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between RFR and FFR measured by Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Bland-Altman analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson's correlation between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Pearson correlation between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Passing-Bablok regression analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire as assessed by Bland-Altman analysis
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results of Bland-Altman analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire among the patients with atrial fibrillation or in severe stenosis or with small vessels
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Rate of significant drift
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Rate of device success
Time frame: Immediate upon completion of the procedure for the last enrolled patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 41823250Zhou J, Yang J, Zhang W, Zu L, Cheng Y, Li M, Ma K, Zhou H, Ma X, Yuan H, Wang Y, Fu G, Li Y, Tang Y, Shi B, Gori T, Qian J, Chen J, Li C, Ge J; SUPREME II Study Investigators. Clinical Validation of a Novel Pressure Microcatheter-Based Nonhyperemic Pressure Ratio (SUPREME II Study). J Am Heart Assoc. 2026 Mar 17;15(6):e041920. doi: 10.1161/JAHA.125.041920. Epub 2026 Mar 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Disease, run by Insight Lifetech Co., Ltd. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia (time frame: Immediate upon completion of the procedure for the last enrolled patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.