Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-02-20 @ 9:38 PM
Study NCT ID:
NCT02154295
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2014-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clarity of Image and ease of interpretation as measured by physician survey', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Scheduled for a coronary angiogram at the Royal Adelaide Hospital.\n* Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized \\[total hysterectomy, bilateral tubal ligation, bilateral oophorectomy\\]).\n* Target artery must be \\>2 mm to accommodate the IVUS catheter.\n* IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)\n* Known coronary artery spasm\n* Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)\n* Bleeding diathesis\n* Significant renal impairment (patients will be excluded if their calculated creatinine clearance is \\< 30 mL/min)'}, 'identificationModule': {'nctId': 'NCT02154295', 'acronym': 'SAVOIR2', 'briefTitle': 'In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infraredx'}, 'officialTitle': 'Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study', 'orgStudyIdInfo': {'id': '0126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eagle Eye Platinum', 'description': 'Eagle Eye Platinum Catheter as the comparator.', 'interventionNames': ['Device: Infraredx Test Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Revolution', 'description': 'Revolution Catheter as the comparator', 'interventionNames': ['Device: Infraredx Test Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TVC Insight 40MHz', 'description': 'TVC Insight as comparative catheter.', 'interventionNames': ['Device: Infraredx Test Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atlantis Pro', 'description': 'Atlantis Pro catheter as comparator', 'interventionNames': ['Device: Infraredx Test Catheter']}], 'interventions': [{'name': 'Infraredx Test Catheter', 'type': 'DEVICE', 'armGroupLabels': ['Atlantis Pro', 'Eagle Eye Platinum', 'Revolution', 'TVC Insight 40MHz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Samuel Sidharta, MBBS BMedSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Adelaide Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infraredx', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'South Australian Health and Medical Research Institute', 'class': 'OTHER'}, {'name': 'Royal Adelaide Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}