Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-01 @ 9:44 PM
Study NCT ID:
NCT05931003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2023-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016894', 'term': 'Endarterectomy, Carotid'}], 'ancestors': [{'id': 'D004691', 'term': 'Endarterectomy'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2023-04-15', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change the degree of arterial hypertension', 'timeFrame': '2 years', 'description': 'Using ambulatory blood pressure monitoring (mmHg)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Carotid Stenosis', 'Symptomatic Carotid Artery Stenosis', 'Glomus ectomy', 'Carotid endarterectomy', 'Carotid Stenting'], 'conditions': ['Hypertension', 'Carotid Stenosis', 'Symptomatic Carotid Artery Stenosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.angiolsurgery.org/magazine/2022/3/', 'label': 'ARTERIAL HYPERTENSION AFTER CAROTID ENDARTERECTOMY AND INTERNAL CAROTID ARTERY STENTING'}]}, 'descriptionModule': {'briefSummary': 'Carotid endarterectomy (CEA) is a well-established procedure for preventing ischemic brain damage. Stenosis of the precerebral vessels are often combined with arterial hypertension. In recent decades, many works have appeared that indicate that the course of arterial hypertension (AH) changes after CEA. However, it remains unknown how this is related to the choice of surgical tactics.', 'detailedDescription': 'Purpose of the study: to substantiate the choice of the method of surgical treatment in patients with a combination of hemodynamically significant stenosis of the carotid bifurcation and arterial hypertension of 2-3 degrees.\n\nTasks:\n\n1. To study the course of hypertension after carotid endarterectomy with removal of the carotid glomus.\n2. To study the course of hypertension in patients after stenting of the internal carotid artery.\n3. To substantiate the strategy for performing carotid endarterectomy in patients with bilateral significant lesions of the internal carotid artery.\n4. To substantiate the choice of a surgical treatment strategy in patients with significant stenosis of the carotid bifurcation and 2-3 degree of hypertension.\n\nMethods for examining patients: collection of complaints and anamnesis, objective examination, questioning of patients, instrumental examination (ultrasound of BCS, daily monitoring of blood pressure, CT of the brain, cerebral angiography).\n\nAs a result of the study, the optimal tactics of surgical treatment in patients with carotid artery stenosis and the presence of hypertension will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of symptomatic ICA stenosis 70-90%\n* Arterial hypertension of 2 or 3 degrees\n* CEA operation with carotid glomus removal or ICA stenting operation\n\nExclusion Criteria:\n\n* severe diabetes\n* traumatic brain injury in history\n* IHD, stable angina pectoris 3-4 FC.\n* presence of clinical signs of vertebrobasilar insufficiency\n* the presence of significant stenosis of the renal arteries\n* CKD stages 3b-5'}, 'identificationModule': {'nctId': 'NCT05931003', 'briefTitle': 'Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees', 'organization': {'class': 'OTHER', 'fullName': 'Samara State Medical University'}, 'officialTitle': 'Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees', 'orgStudyIdInfo': {'id': 'Hypertension_after_CEA_or_CAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carotid artery stenting', 'description': 'Carotid artery stenting', 'interventionNames': ['Procedure: Carotid stenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid endarterectomy', 'description': 'Carotid endarterectomy', 'interventionNames': ['Procedure: Carotid endarterectomy']}], 'interventions': [{'name': 'Carotid stenting', 'type': 'PROCEDURE', 'description': 'In carotid stenting, a long, hollow tube (catheter) is threaded through the arteries to the narrowed carotid artery in the neck. A metal mesh tube (stent) is inserted into the vessel to serve as a scaffold that helps prevent the artery from narrowing again. The catheter and the filter - which catches any debris that may break off during the procedure - are removed.', 'armGroupLabels': ['Carotid artery stenting']}, {'name': 'Carotid endarterectomy', 'type': 'PROCEDURE', 'description': 'Carotid endarterectomy is a procedure to treat carotid artery disease. In carotid endarterectomy receive general anesthesia. Surgeon makes an incision along the front of your neck, opens your carotid artery and removes the plaques that are clogging artery. Then, surgeon repairs the artery with stitches or a patch made with a vein or artificial material (patch graft).\n\nSometimes surgeons may use another technique called eversion carotid endarterectomy. This involves cutting the carotid artery and turning it inside out, then removing the plaque. Surgeon then reattaches the artery.', 'armGroupLabels': ['Carotid endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samara', 'country': 'Russia', 'facility': 'Samara State Medical University', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samara State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}