Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT06974760
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of intraoperative adverse effects', 'timeFrame': 'From enrollment to the end of treatment at one weeks', 'description': 'Rate of device-related adverse effects, for each system individually, and comparison between the two systems.'}, {'measure': 'Rate of successful use of instruments', 'timeFrame': 'From enrollment to the end of treatment at one weeks', 'description': 'Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems'}], 'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': 'From enrollment to the end of treatment at one week', 'description': 'Measure the Mean Stent Area in square millimeter(MSA)\n\nComparison 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 .'}], 'secondaryOutcomes': [{'measure': 'Minimal Lumen Area in square millimeter(MLA)', 'timeFrame': 'Estimated 1 month on average, by a third-party corelab IVUS image post-analysis', 'description': '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.'}, {'measure': 'Stent Length in millimeter (SL)', 'timeFrame': 'Estimated 1 month on average, by a third-party corelab IVUS image post-analysis', 'description': '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.'}, {'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', 'description': 'Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems.'}, {'measure': 'Identification plaque properties', 'timeFrame': 'Estimated 1 month on average, by a third-party corelab IVUS image post-analysis', 'description': 'Rates of lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems'}, {'measure': 'Stability of system(questionnaire)', 'timeFrame': "estimated 1week on average, by opeartor's rating on questionaire", 'description': '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.'}, {'measure': 'Maneuvering performance of catheter(questionnaire)', 'timeFrame': "estimated 1week on average, by opeartor's rating on questionaire", 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Coronary Intervention (PCI)', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety and efficacy of IVUS Console and IVUS Catheter in coronary intervention therapy\n\nParticipants will:\n\nUndergo IVUS examinations from two different manufacturers（from Pulse and Boston Scientific）'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged ≥ 18 years old;\n2. Subjects who require coronary artery intravascular ultrasound (IVUS) guidance prior to stent implantation upon clinical judgment;\n3. Subjects who are able to understand and willing to sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Subjects who are not suitable for percutaneous coronary stent implantation;\n2. Subjects who are diagnosed with coronary artery spasm;\n3. Subjects with a history of allergy to contrast agents;\n4. Subjects who are participating in other clinical trials and have not yet reached the primary endpoint;\n5. Subjects who are deemed ineligible to be included in this trial by the investigator.'}, 'identificationModule': {'nctId': 'NCT06974760', 'acronym': 'IVUS', 'briefTitle': 'A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulse Medical Imaging Technology (Shanghai) Co., Ltd'}, 'officialTitle': 'A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures', 'orgStudyIdInfo': {'id': 'BD-IVUS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Boston IVUS', 'interventionNames': ['Device: IVUS']}, {'type': 'OTHER', 'label': 'Pluse IVUS', 'interventionNames': ['Device: IVUS']}], 'interventions': [{'name': 'IVUS', 'type': 'DEVICE', 'description': 'The Participants will receive IVUS examinations from Pulse and Boston', 'armGroupLabels': ['Boston IVUS', 'Pluse IVUS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital. Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'The Sixth Medical Center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulse Medical Imaging Technology (Shanghai) Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}