Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 12:20 AM
Study NCT ID:
NCT02722720
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2016-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2016-03-13', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral embolism', 'timeFrame': 'during 24 hours after carotid artery stenting', 'description': 'Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.'}], 'secondaryOutcomes': [{'measure': 'Cerebral embolism', 'timeFrame': 'intraoperative', 'description': 'Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.'}, {'measure': 'MACCE', 'timeFrame': 'during 30 days after carotid artery stenting', 'description': 'Major adverse cardiac and cerebrovascular events (MACCE) including: including: All-cause mortality, Myocardial infarction, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.'}, {'measure': 'Neurocognitive disorders', 'timeFrame': 'before and 30 days after carotid artery stenting', 'description': 'Mini-Mental State Examination (MMSE)'}, {'measure': 'Neurocognitive disorders', 'timeFrame': 'before and 30 days after carotid artery stenting', 'description': 'Rey Auditory Verbal Learning Test (RALVT)'}, {'measure': 'Neurocognitive disorders', 'timeFrame': 'before and 30 days after carotid artery stenting', 'description': 'Grooved Pegboard test'}, {'measure': 'Neurocognitive disorders', 'timeFrame': 'before and 30 days after carotid artery stenting', 'description': 'Boston Naming Test'}, {'measure': 'Neurocognitive disorders', 'timeFrame': 'before and 30 days after carotid artery stenting', 'description': 'Geriatric Depression Scale'}, {'measure': 'Neurocognitive disorders', 'timeFrame': 'before and 30 days after carotid artery stenting', 'description': 'Weschler Test of Adult Reading (WTAR)'}, {'measure': 'Device success', 'timeFrame': 'intraoperative', 'description': 'Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.'}, {'measure': 'Lesion success', 'timeFrame': 'intraoperative', 'description': 'Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.'}, {'measure': 'In-hospital procedure success', 'timeFrame': 'Within 5-day hospitalization', 'description': 'Procedure success is defined as achievement of a final residual diameter stenosis 20% together with the absence of any in-hospital major adverse cardiac event.'}, {'measure': 'Operative access complications', 'timeFrame': 'intraoperative/ 1 day after operation', 'description': 'Bleeding, aneurisms, large hematomas, atrioventricular fistula'}, {'measure': 'Fluoroscopic time', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carotid atherosclerosis', 'Carotid stenosis', 'Ischemic attack', 'Stroke', 'Carotid stenting', 'Transradial approach', 'Transfemoral approach', 'Bleeding', 'Thromboembolism', 'Embolism', 'Neurocognitive disorders'], 'conditions': ['Carotid Atherosclerosis', 'Carotid Stenosis', 'Ischemic Attack', 'Stroke', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.', 'detailedDescription': 'The use of transradial approach in carotid arteries stenting can significantly decrease the amount of adverse events associated with transfemoral approach such as bleeding or hematoma. Otherwise providing transradial approach is fraught with technical difficulties of common carotid artery canulation that can result in embolic complications. Taking into account the absence of studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic patients with internal carotid artery stenosis(\\>50%)\n* Asymptomatic patients with internal carotid artery stenosis(\\>60%)\n* Anatomy of internal carotid artery applicable for stent implantation and use of embolic protection device\n\nExclusion Criteria:\n\n* Stroke, myocardial infarction or underwent operative treatment within 1 month\n* Prior carotid artery stenting\n* Cerebral vessels aneurisms/ malformations\n* Subclavian artery/ brachiocephalic trunk stenosis\n* Contraindications for antiplatelet or/and anticoagulation therapy'}, 'identificationModule': {'nctId': 'NCT02722720', 'briefTitle': 'Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach', 'orgStudyIdInfo': {'id': 'CASTE-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carotid stenting, Transradial approach', 'description': 'Internal carotid artery stenting using transradial arterial approach', 'interventionNames': ['Procedure: Transradial carotid artery stenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid stenting, Transfemoral approach', 'description': 'Internal carotid artery stenting using transfemoral arterial approach', 'interventionNames': ['Procedure: Transfemoral carotid artery stenting']}], 'interventions': [{'name': 'Transradial carotid artery stenting', 'type': 'PROCEDURE', 'description': 'The radial artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.', 'armGroupLabels': ['Carotid stenting, Transradial approach']}, {'name': 'Transfemoral carotid artery stenting', 'type': 'PROCEDURE', 'description': 'The common femoral artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.', 'armGroupLabels': ['Carotid stenting, Transfemoral approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'State Research Institute of CIrculation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}