Status:
COMPLETED
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
Lead Sponsor:
Insight Lifetech Co., Ltd.
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Guangdong Provincial People's Hospital
Conditions:
Coronary Artery Disease
Coronary Disease
Eligibility:
All Genders
18+ years
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 validat...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT05417763
Start Date
February 28 2022
End Date
December 1 2022
Last Update
December 20 2023
Active Locations (11)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China
2
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
3
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian, China
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China