Study record managers: refer to the Data Element Definitions if submitting registration or results information. Many studies have reported that IVUS is an accurate method Cihldren determining optimal stent development complete stent expansion and apposition and lack of edge dissection or other complications after implantationand the size of the vessel undergoing stent implantation. The secondary purpose is to analyze the feasibility of high-speed pullback in the assessment of IVUS. A total of patients will be recruited at 6 centers in China. Intravascular ultrasound imaging is used in patients who will undergo transluminal coronary intervention.
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Criteria Inclusion Criteria:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms x. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
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Study Description. InSight Lifetech Intravascular Ultrasound Diagnostic System referred to as InSight Lifetech IVUS system below ,is a new high-speed and high-resolution device for providing clear images of plague morphology, as well as the quantitative and qualitative assessment of coronary artery. Detailed Description:.
FDA Resources. Outcome Measures. Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems. Use the questionnaire to evaluate stability of system host, including the stability of IVUS examination, the usability of system operation, and the definition of images, for each system individually, Evvaluation comparison between the two systems. Trackability of catheter, including the pushability,the traceability and the development effect, for each catheter individually, and comparison between the two catheters.
Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems. Rate of device-related adverse effects, for each system individually, and comparison between the two systems.
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Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Age: 18 Years and older; Understand and willing to sign the informed consent form; Clinical evaluation shows that the coronary artery stent implantation and the intravascular ultrasound IVUS guidance is required. Exclusion Criteria: Unable to understand or unwilling to sign the informed consent form; Clinically diagnosed with severe coronary artery spasms; Contraindications for percutaneous coronary intervention PCI ; Presence of any other factor that the investigator deems is unsuitable for enrollment or completion of this study.
Contacts and Locations. Information from the National Library of Medicine To learn more about Childrne study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.]
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