Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT05257161
Status:
RECRUITING
Last Update Posted:
2022-02-25
First Post:
2022-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 366}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determination of ischemic lesions', 'timeFrame': '24-48 hours', 'description': 'Postprocedural acute ischemic lesions (MRI)'}], 'secondaryOutcomes': [{'measure': 'MACCE', 'timeFrame': 'Intraoperatively, and within 48 hours.', 'description': 'Death, stroke, and MI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carotid artery stenting. CGuard stent. Protection Device.'], 'conditions': ['Patients With Aterosclerotic Carotid Stenosis', 'Symptomatic Patients (Stenosis > 50%)', 'Asymptomatic Patients (Stenosis ≥80%)']}, 'referencesModule': {'references': [{'pmid': '32007460', 'type': 'RESULT', 'citation': 'Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31855202/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.\n2. More than 6-month life expectancy\n3. Suitable clinical conditions for performing DW-MRI\n4. Written Informed consent approved by the Ethics Committee\n5. Subject agrees to all required follow-up procedures and visits\n\nExclusion Criteria:\n\n1. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints\n2. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure\n3. Hepatic active disease (bilirubin\\> 35 mmol / l) or renal insufficiency (serum creatinine \\> 2.5 mg/dL or glomerular filtration rate \\<60 ml / min)\n4. Recent evolving acute stroke within 30-days of study evaluation\n5. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB \\> 3 times normal)\n6. Female patients of childbearing potential or known to be pregnant\n7. Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia\n8. Patient on VKA or new oral anticoagulants"}, 'identificationModule': {'nctId': 'NCT05257161', 'acronym': 'SIBERIA-2', 'briefTitle': 'Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS', 'orgStudyIdInfo': {'id': 'SIBERIA 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))', 'description': '183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))', 'interventionNames': ['Device: Emboshield NAV6™']}, {'type': 'EXPERIMENTAL', 'label': 'MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)', 'description': '183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS))', 'interventionNames': ['Device: Mo.Ma™']}], 'interventions': [{'name': 'Emboshield NAV6™', 'type': 'DEVICE', 'otherNames': ['Emboshield NAV6™ Embolic Protection System'], 'description': 'Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™', 'armGroupLabels': ['Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))']}, {'name': 'Mo.Ma™', 'type': 'DEVICE', 'otherNames': ['Mo.Ma™ proximal cerebral protection device'], 'description': 'Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™', 'armGroupLabels': ['MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Andrey A Karpenko, MD', 'role': 'CONTACT', 'email': 'a_karpenko@meshalkin.ru'}], 'facility': 'E. Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Andrey A Kaprenko, MD', 'role': 'CONTACT', 'email': 'a_karpenko@meshalkin.ru', 'phone': '+79139504100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, {'name': 'Chelyabinsk Regional Clinical Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}