Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT04593667
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2020-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Study of Accelerated Radial Arterial Hemostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-05-27', 'mcpReleaseN': 3, 'releaseDate': '2022-05-02'}], 'estimatedResultsFirstSubmitDate': '2022-05-02'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '60 patients, randomized into one of three arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to hemostasis', 'timeFrame': '60 minutes', 'description': 'Significant change in time to hemostasis'}, {'measure': 'Compressive Force', 'timeFrame': '60 minutes', 'description': 'Change in the compressive force onto the access site'}], 'secondaryOutcomes': [{'measure': 'Radial Artery', 'timeFrame': 'immediately after hemostasis', 'description': 'Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemostasis']}, 'descriptionModule': {'briefSummary': 'Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage', 'detailedDescription': 'The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, \\& N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04593667', 'acronym': 'GOLOW', 'briefTitle': 'Randomized Study of Accelerated Radial Arterial Hemostasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medcura Inc.'}, 'officialTitle': 'Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention', 'orgStudyIdInfo': {'id': 'WIRB Protocol 20202766'}, 'secondaryIdInfos': [{'id': '1291856', 'type': 'OTHER', 'domain': 'WIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Full Inflation', 'description': '100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder', 'interventionNames': ['Device: hm-P bandage']}, {'type': 'OTHER', 'label': 'Mid Inflation', 'description': '75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder', 'interventionNames': ['Device: hm-P bandage']}, {'type': 'OTHER', 'label': 'Low Inflation', 'description': '50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder', 'interventionNames': ['Device: hm-P bandage']}], 'interventions': [{'name': 'hm-P bandage', 'type': 'DEVICE', 'description': 'hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.', 'armGroupLabels': ['Full Inflation', 'Low Inflation', 'Mid Inflation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital - Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Varinder Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medcura Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Northwell Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}