Status:
COMPLETED
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
Lead Sponsor:
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Conditions:
Percutaneous Coronary Intervention (PCI)
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the safety and efficacy of IVUS Console and IVUS Catheter in coronary intervention therapy Participants will: Undergo IVUS examinations from two differ...
Eligibility Criteria
Inclusion
- Subjects aged ≥ 18 years old;
- Subjects who require coronary artery intravascular ultrasound (IVUS) guidance prior to stent implantation upon clinical judgment;
- Subjects who are able to understand and willing to sign the informed consent form (ICF).
Exclusion
- Subjects who are not suitable for percutaneous coronary stent implantation;
- Subjects who are diagnosed with coronary artery spasm;
- Subjects with a history of allergy to contrast agents;
- Subjects who are participating in other clinical trials and have not yet reached the primary endpoint;
- Subjects who are deemed ineligible to be included in this trial by the investigator.
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06974760
Start Date
July 20 2023
End Date
April 17 2025
Last Update
July 31 2025
Active Locations (4)
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1
Beijing Anzhen Hospital. Capital Medical University
Beijing, China
2
The Sixth Medical Center of PLA General Hospital
Beijing, China
3
Shanghai Tongji Hospital
Shanghai, China
4
Shanghai Zhongshan Hospital
Shanghai, China