A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
NCT ID: NCT06974760
Last Updated: 2025-07-31
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
NA
150 participants
INTERVENTIONAL
2023-07-20
2025-04-17
Brief Summary
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Participants will:
Undergo IVUS examinations from two different manufacturers（from Pulse and Boston Scientific）
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Boston IVUS
IVUS
The Participants will receive IVUS examinations from Pulse and Boston
Pluse IVUS
IVUS
The Participants will receive IVUS examinations from Pulse and Boston
Interventions
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IVUS
The Participants will receive IVUS examinations from Pulse and Boston
Eligibility Criteria
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Inclusion Criteria
2. Subjects who require coronary artery intravascular ultrasound (IVUS) guidance prior to stent implantation upon clinical judgment;
3. Subjects who are able to understand and willing to sign the informed consent form (ICF).
Exclusion Criteria
2. Subjects who are diagnosed with coronary artery spasm;
3. Subjects with a history of allergy to contrast agents;
4. Subjects who are participating in other clinical trials and have not yet reached the primary endpoint;
5. Subjects who are deemed ineligible to be included in this trial by the investigator.
18 Years
ALL
No
Sponsors
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Pulse Medical Imaging Technology (Shanghai) Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital. Capital Medical University
Beijing, , China
The Sixth Medical Center of PLA General Hospital
Beijing, , China
Shanghai Tongji Hospital
Shanghai, , China
Shanghai Zhongshan Hospital
Shanghai, , China
Countries
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Other Identifiers
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BD-IVUS-002
Identifier Type: -
Identifier Source: org_study_id
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