Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04911218
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2021-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-12', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful hemostasis at 30 minutes after sheath removal', 'timeFrame': 'At 30 minutes after sheath removal'}], 'secondaryOutcomes': [{'measure': 'Crossover rate to conventional radial access', 'timeFrame': 'During the procedure'}, {'measure': 'Pain associated with the procedure (visual analog scale, VAS)', 'timeFrame': 'During the procedure', 'description': '0-10, 0: no pain, 10: worst pain possible'}, {'measure': 'Rate of hematoma modified EASY class≥II', 'timeFrame': 'Up to 24 hours after hemostatic device removal'}, {'measure': 'Rate of forearm radial artery occlusion', 'timeFrame': '7-10 days after the coronary angiography'}, {'measure': 'Rate of distal radial artery occlusion', 'timeFrame': '7-10 days after the coronary angiography'}, {'measure': 'Rate of fistula formation', 'timeFrame': '7-10 days after the coronary angiography'}, {'measure': 'Rate of pseudoaneurysm formation', 'timeFrame': '7-10 days after the coronary angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arterial access', 'coronary angiography', 'radial access', 'distal radial access', 'radial artery occlusion'], 'conditions': ['Arterial Access', 'Coronary Angiography', 'Radial Artery Occlusion']}, 'descriptionModule': {'briefSummary': 'Transradial approach has become the default arterial access for coronary angiography (CAG) and percutaneous coronary intervention (PCI), mainly due to lower incidence of bleeding compared to transfemoral access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. Recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dTRA), located in the anatomical snuffbox. Initial studies regarding the dRA have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of RAO.\n\nGlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. As a result, the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths.\n\nThe purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (RAO, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.', 'detailedDescription': 'Patients fulfilling the enrollment criteria will be randomized 1:1 to GlideSheath Slender versus conventional 5Fr arterial sheath for access through the distal radial artery (dTRA). In case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis.\n\nFor randomized patients sheath insertion time, necessity for crossover to conventional radial access, pain associated with the procedure (visual pain scale) and occurrence of hematoma will be recorded. Follow-up ultrasound 7-10 days after the procedure for detection of RAO, distal radial artery occlusion and fistula formation will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for coronary angiography\n* Age\\>18 years\n* Informed consent\n\nExclusion Criteria:\n\n* Non-palpable right radial artery\n* Prior CABG\n* STEMI\n* Prior right transaradial intervention within the previous 2 months\n* Hemodynamic instability\n* Anatomical restrictions (fistula orthopaedic problems, etc)'}, 'identificationModule': {'nctId': 'NCT04911218', 'briefTitle': 'GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)', 'orgStudyIdInfo': {'id': '1762/22.01.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GlideSheath Slender 5Fr arterial sheath', 'description': 'Placement of GlideSheath Slender 5Fr arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox).', 'interventionNames': ['Device: GlideSheath Slender 5Fr arterial sheath']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional 5Fr arterial sheath', 'description': 'Placement of Conventional 5Fr arterial sheath arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox).', 'interventionNames': ['Device: Conventional 5Fr arterial sheath']}], 'interventions': [{'name': 'GlideSheath Slender 5Fr arterial sheath', 'type': 'DEVICE', 'description': 'Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).', 'armGroupLabels': ['GlideSheath Slender 5Fr arterial sheath']}, {'name': 'Conventional 5Fr arterial sheath', 'type': 'DEVICE', 'description': 'Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).', 'armGroupLabels': ['Conventional 5Fr arterial sheath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26504', 'city': 'Pátrai', 'state': 'Achaia', 'country': 'Greece', 'facility': 'University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Cardiology', 'investigatorFullName': 'Grigorios Tsigkas', 'investigatorAffiliation': 'University Hospital of Patras'}}}}