Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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）
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boston IVUS | Other |
| |
| Pluse IVUS | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS | Device | The Participants will receive IVUS examinations from Pulse and Boston |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | 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 . | From enrollment to the end of treatment at one week |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Lumen Area in square millimeter(MLA) | 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. | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of intraoperative adverse effects | Rate of device-related adverse effects, for each system individually, and comparison between the two systems. | From enrollment to the end of treatment at one weeks |
| Rate of successful use of instruments |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital. Capital Medical University | Beijing | China | ||||
| The Sixth Medical Center of PLA General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stent Length in millimeter (SL) | 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. | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis |
| The rate of detected stent malapposition, tissue prolapse and dissection | Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems. | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis |
| Identification plaque properties | Rates of lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems | Estimated 1 month on average, by a third-party corelab IVUS image post-analysis |
| Stability of system(questionnaire) | 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. | estimated 1week on average, by opeartor's rating on questionaire |
| Maneuvering performance of catheter(questionnaire) | 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. | estimated 1week on average, by opeartor's rating on questionaire |
Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems
| From enrollment to the end of treatment at one weeks |
| Beijing |
| China |
| Shanghai Tongji Hospital | Shanghai | China |
| Shanghai Zhongshan Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided