Percutaneous Coronary Intervention (PCI), Coronary Artery Disease
Conditions
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 different manufacturers（from Pulse and Boston Scientific）
Interventions
DEVICEIVUS
The Participants will receive IVUS examinations from Pulse and Boston
Sponsors
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects aged ≥ 18 years old; 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
1. Subjects who are not suitable for percutaneous coronary stent implantation; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | From enrollment to the end of treatment at one week | Measure the Mean Stent Area in square millimeter(MSA) Comparison between the MSA measured by the Pulse and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Lumen Area in square millimeter(MLA) | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis | Comparison between the MLA measured by the Pubmed Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, as assessed by Bland-Altman analysis and Pearson analysis. |
| Stent Length in millimeter (SL) | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis | Comparison between the SL measured by the Pubmed Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, as assessed by Bland-Altman analysis and Pearson analysis. |
| The rate of detected stent malapposition, tissue prolapse and dissection | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis | Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems. |
| Stability of system(questionnaire) | estimated 1week on average, by opeartor's rating on questionaire | Evaluate the stability, ease of use, and clarity of captured images of the both IVUS systems from all enrolled case. Each performance includes three options: excellent, good, and poor. |
| Maneuvering performance of catheter(questionnaire) | estimated 1week on average, by opeartor's rating on questionaire | Evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures :the pushability，the crossability and the angiographic visibility，Each performance includes three options: excellent, good, and poor. |
| Identification plaque properties | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis | Rates of lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of intraoperative adverse effects | From enrollment to the end of treatment at one weeks | Rate of device-related adverse effects, for each system individually, and comparison between the two systems. |
| Rate of successful use of instruments | From enrollment to the end of treatment at one weeks | Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems |
Countries
China
Outcome results
None listed