Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
NCT ID: NCT05417763
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
487 participants
OBSERVATIONAL
2022-02-28
2022-12-01
Brief Summary
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Detailed Description
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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* if cRR or RFR of the target vessel is between A and B (including A and B), the diagnostic criterion is superseded by that of FFR, which is: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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
* Clinically indicated to physiological assessment.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Peking University Third Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Sir Run Run Shaw Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Zunyi Medical College
OTHER
Xiamen Cardiovascular Hospital, Xiamen University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Insight Lifetech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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CTP-01-001
Identifier Type: -
Identifier Source: org_study_id