Status:
COMPLETED
Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System
Lead Sponsor:
Insight Lifetech Co., Ltd.
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Guangdong Provincial People's Hospital
Conditions:
Percutaneous Coronary Intervention
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture ...
Detailed Description
Many studies have reported that IVUS is an accurate method for determining the size of the target vessel undergoing stent implantation , and the optimal stent deployment (complete stent expansion and ...
Eligibility Criteria
Inclusion
- Age: 18 Years and older;
- Understand and willing to sign the informed consent form;
- Clinical evaluation shows that the coronary artery stent implantation and the intravascular ultrasound(IVUS) guidance is required.
Exclusion
- Unable to understand or unwilling to sign the informed consent form;
- Clinically diagnosed with severe coronary artery spasms;
- Contraindicated to percutaneous coronary intervention (PCI);
- Presence of any other factor that the investigator deems is unsuitable for enrollment or completion of this study.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04739657
Start Date
March 1 2021
End Date
April 27 2021
Last Update
May 11 2022
Active Locations (5)
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1
The General Hospital of the People's Liberation Army
Beijing, China
2
Guangdong Provincial People's Hospital
Guangzhou, China
3
Zhongda Hospital of Southeast University
Nanjing, China
4
Shanghai Zhongshan Hospital
Shanhai, China