Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT04533503
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2020-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vis-Rx Post-Market Evaluation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance', 'timeFrame': 'Immediately after the procedure', 'description': 'Operator evaluation of performance via Likert scale'}, {'measure': 'Technical performance', 'timeFrame': 'Up to 3 months following the procedure', 'description': 'Objective measurement of image clarity of the HF-OCT images by an independent core lab'}], 'secondaryOutcomes': [{'measure': 'Complete pullbacks', 'timeFrame': 'Up to 3 months following the procedure', 'description': 'Percentage of HF-OCT images with maximum clear image length'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.', 'detailedDescription': 'Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Willing and able to provide written informed consent to participate\n* Transluminal interventional procedure for their coronary arteries\n\nGeneral Exclusion Criteria:\n\n* Bacteremia or sepsis\n* Major coagulation system abnormalities\n* Severe hemodynamic instability or shock\n* Acute renal failure\n* Disqualified for Coronary Artery Bypass Graft (CABG) surgery\n* Disqualified for PCI procedure\n* Currently enrolled in another study to evaluate an investigational device or medication\n\nLesion-Specific Exclusion Criteria:\n\n* Total occlusion\n* Coronary artery spasm\n* Large thrombus (visible under angiography)\n* Any target vessel which has undergone a bypass procedure'}, 'identificationModule': {'nctId': 'NCT04533503', 'acronym': 'Vis-Rx PME', 'briefTitle': 'Vis-Rx Post-Market Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gentuity, LLC'}, 'officialTitle': 'Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter', 'orgStudyIdInfo': {'id': '003175'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HF-OCT imaging', 'description': 'Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging', 'interventionNames': ['Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter']}], 'interventions': [{'name': 'HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter', 'type': 'DEVICE', 'description': 'Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.', 'armGroupLabels': ['HF-OCT imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gentuity, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}