Clinical trial NCT06974760: Clinical Evaluation of Intravascular Ultrasound Diagnostic Equipment and Intravascular Ultrasound Diagnostic Catheter
Official title: Clinical Evaluation of Intravascular Ultrasound Diagnostic Equipment and Intravascular Ultrasound Diagnostic Catheter Safety and Effectiveness in Coronary Intervention Surgery Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention (PCI)
Coronary Artery Disease
Lead sponsor: Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the safety and effectiveness of intravascular ultrasound diagnostic instruments（referred to as Pubmed IVUS system） and disposable intravascular ultrasound diagnostic catheters（referred to as Pubmed IVUS catheters） in coronary intervention therapy.

Participants will:

Undergo IVUS examinations from two different manufacturers（from Pubmed and Boston Scientific）


Eligibility criteria: Inclusion Criteria:

* Age: 18 Years and older;
* Clinical evaluation shows that the coronary artery stent implantation and the intravascular ultrasound(IVUS) guidance is required.
* Understand and willing to sign the informed consent form;

Exclusion Criteria:

* Participants who are not suitable for percutaneous coronary stent implantation;
* Participants diagnosed with coronary artery spasm；
* Participants with a history of allergy to contrast agents;
* Participants in other clinical trials who have not yet reached the primary endpoint；
* The investigator believe that the subjects are not suitable for inclusion in this study.

Primary outcomes:
measure: Effectiveness
timeFrame: From enrollment to the end of treatment at one week
Secondary outcomes:
measure: Minimal Lumen Area in square millimeter(MLA)
timeFrame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: Stent Length in millimeter (SL)
timeFrame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: The rate of detected stent malapposition, tissue prolapse and dissection
timeFrame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: Identification plaque properties
timeFrame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: Stability of system(questionnaire)
timeFrame: estimated 1week on average, by opeartor's rating on questionaire
measure: Maneuvering performance of catheter(questionnaire)
timeFrame: estimated 1week on average, by opeartor's rating on questionaire
Other outcomes:
measure: Rate of intraoperative adverse effects
timeFrame: From enrollment to the end of treatment at one weeks
measure: Rate of successful use of instruments
timeFrame: From enrollment to the end of treatment at one weeks
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital. Capital Medical University
city: Beijing
country: China
facility: The Sixth Medical Center of PLA General Hospital
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
References: