Clinical trial NCT05417763: Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
Official title: Pressure Microcatheter for Physiological Measurements - A Prospective, Multicenter, Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Keywords: fractional flow reserve
constant-resistance ratio
resting full-cycle ratio
Lead sponsor: Insight Lifetech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
name: Guangdong Provincial People's Hospital
name: Peking University Third Hospital
name: First Affiliated Hospital of Harbin Medical University
name: Sir Run Run Shaw Hospital
name: Shandong Provincial Hospital
name: Zunyi Medical College
name: Xiamen Cardiovascular Hospital, Xiamen University
name: First Affiliated Hospital of Xinjiang Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2022-06-14
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with coronary artery disease.

Brief 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). 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.

Eligibility 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.

Primary outcomes:
measure: The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
Secondary outcomes:
measure: The area under the Receiver Operating Characteristic (ROC) curve (AUC) of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The sensitivity, specificity, positive and negative predictive values of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The AUC of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The overall accuracy, sensitivity, specificity, positive and negative predictive values of cRR in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The AUC of RFR measured by the Pressure Wire in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The overall accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RFR in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: 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
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The proportion of the subcohort, whose cRR value is in the gray zone of the hybrid cRR-FFR scheme, to the entire cohort
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: 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
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid RFR-FFR scheme, concluded by Pressure Wire, in diagnosing myocardial ischemia
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: The proportion of the subcohort, whose RFR value is in the gray zone of the hybrid RFR-FFR scheme, to the entire cohort
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: 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
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Pearson correlation between the cRR and FFR measured by TruePhysio pressure microcatheter
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Passing-Bablok regression analysis between the cRR and FFR measured by TruePhysio pressure microcatheter
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Pearson correlation between the RFR and FFR measured by Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Passing-Bablok regression analysis between RFR and FFR measured by Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Passing-Bablok regression analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Bland-Altman analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Pearson's correlation between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Pearson correlation between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Results of Passing-Bablok regression analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire as assessed by Bland-Altman analysis
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: 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
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Rate of significant drift
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
measure: Rate of device success
timeFrame: Immediate upon completion of the procedure for the last enrolled patient
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital, Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Harbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: