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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Zhongda Hospital |
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Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology, providing quantitative and qualitative assessment of coronary arteries. Besides, IVUS has already an established role in guidance and optimization of percutaneous coronary intervention. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) results measured by the two different IVUS diagnostic systems.
Many studies have reported that IVUS is an accurate method for determining the size of the target vessel undergoing stent implantation , and the optimal stent deployment (complete stent expansion and apposition and lack of edge dissection or other complications after implantation). The novel 60 megahertz(60MHz) high-definition IVUS has evolved as a next-generation IVUS imaging technology to provide higher image resolution than conventional 40 megahertz(40MHz) IVUS but with sufficient imaging depth preserved for the assessment of the entire vessel wall structure.
Insight Lifetech IVUS system includes TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic console. It is a novel device with high speed, high resolution, and high image acquisition rate enabling high-speed pullback imaging up to 10mm/sec.
This study is a prospective, multi-center, randomized, single-blind, controlled study with the primary target of investigating the differences, if any, between IVUS measurement results by the Insight Lifetech IVUS system and Boston Scientific IVUS system, imaging catheter of which was available at 40MHz during the study. Other purposes included analyzing the feasibility of the Insight Lifetech IVUS system's high-speed pullback during the IVUS assessment. A total of 130 patients will be recruited from 5 centers in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Subjects whose clinical conditions require stent implantation, and the interventional procedure of which needs the guidance of IVUS imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insight Lifetech IVUS System | Device | The Insight Lifetech IVUS System is intended for examination of coronary intravascular pathology only, including TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Stent Area in square millimeter(MSA) | Comparison between the MSA measured by the Insight Lifetech Intravascular Ultrasound Diagnositic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson correlation analysis. | estimated 1 month on average, by a third-party corelab IVUS image post-analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Clear Stent Length in millimeter (CSL) | Comparison between the CSL measured by the Insight Lifetech Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson analysis. | estimated 1 month on average, by a third-party corelab IVUS image post-analysis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with coronary artery disease which needs the qualitative and quantitative assessment by IVUS mearsurement, for whom the IVUS guidance during pre- and post-PCI is required.
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, MD, PhD | Zhongshan Hospital of Fudan Unviersity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of the People's Liberation Army | Beijing | China | ||||
| Guangdong Provincial People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Li C, Yang J, Wang X, et al. CLINICAL VALIDATION OF A NEW INTRAVASCULAR ULTRASOUND SYSTEM: A COMPARATIVE ANALYSIS ON LENGTH MEASUREMENTS. J Am Coll Cardiol. 2022 Mar, 79 (9_Supplement) 827. |
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| OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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| Boston Scientific IVUS System | Device | The Boston Scientific IVUS System is intended for the examination of coronary intravascular pathology only, including Opticross IVUS diagnostic catheter and iLAB IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention. |
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| Minimal Lumen Area in square millimeter(MLA) | Comparison between the MLA measured by the Insight Lifetech Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, 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 |
| Stability of system (questionnaire) | Evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures :
For each system in 1., 2., and 3., only one of the following five ratings is given:
and is counted as 1 point for that particular rating. The distribution of the points in rating and how many points each rating individually owns are compared between the systems. | 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 :
For each system in 1., 2., and 3., only one of the following five ratings is given:
and is counted as 1 point for that particular rating. The distribution of the points in rating and how many points each rating individually owns are compared between the systems. | estimated 1week on average, by opeartor's rating on questionaire |
| Device success rate | Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems. | estimated 1day on average, by intraoperative monitoring |
| Rate of device-related adverse effects | Rate of device-related adverse effects, for each system individually, and comparison between the two systems. | estimated 1day on average, by intraoperative monitoring |
| Rate of thrombosis, diffuse lesion and re-stenosis as discerned by IVUS | Rate of thrombosis, diffuse lesion and re-stenosis 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 |
| Rate of plaque rupture and plaque properties as discerned by IVUS | Rates of plaque rupture, 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 |
| Guangzhou |
| China |
| Zhongda Hospital of Southeast University | Nanjing | China |
| Shanghai Zhongshan Hospital | Shanhai | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 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 |
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