Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01340612
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2011-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stenting in the Treatment of Aneurysm Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial 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': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2011-04-21', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of target aneurysm', 'timeFrame': '12 months', 'description': 'rate of angiographic recurrence'}], 'secondaryOutcomes': [{'measure': 'Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events', 'timeFrame': '30 days', 'description': 'Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention'}, {'measure': 'Rate of mortality and morbidity defined as the number of subjects with a disabling neurological events as measured by a modified Rankin Score greater than 2 during the follow-up period', 'timeFrame': '12 months', 'description': 'A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment'}, {'measure': 'Overall morbidity and mortality given by the modified Rankin Score', 'timeFrame': '12 months', 'description': 'Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline'}, {'measure': 'Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%', 'timeFrame': '12 months', 'description': 'luminal diameter will be evaluated by an independent Core Lab'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['large aneurysm', 'wide-necked aneurysm', 'recurring aneurysm'], 'conditions': ['Intracranial Aneurysm']}, 'referencesModule': {'references': [{'pmid': '24849854', 'type': 'DERIVED', 'citation': 'Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.'}, {'pmid': '21990519', 'type': 'DERIVED', 'citation': 'Darsaut TE, Raymond J; STAT Collaborative Group. The design of the STenting in Aneurysm Treatments (STAT) trial. J Neurointerv Surg. 2012 May;4(3):178-81. doi: 10.1136/neurintsurg-2011-010065. Epub 2011 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (\\>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial\n* The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting\n* The endovascular physician is a priori content to use either type of technique\n* The patient has not previously been randomized into the trial\n* Treatment is elective\n* Patient is 18 or older\n* Life expectancy is more than 2 years\n* Patient has given fully informed consent and has signed consent form\n\nExclusion Criteria:\n\n* Other aneurysms requiring treatment during the same session\n* Patients with associated cerebral arteriovenous malformations\n* Patients with recently ruptured aneurysms\n* When parent vessel occlusion is the primary intent of the procedure\n* Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel\n* Patients with recurring, previously stented aneurysms'}, 'identificationModule': {'nctId': 'NCT01340612', 'acronym': 'STAT', 'briefTitle': 'Stenting in the Treatment of Aneurysm Trial', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms', 'orgStudyIdInfo': {'id': 'CE10.111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'coiling', 'description': 'endovascular coiling with any type of currently approved coil (first or second generation)', 'interventionNames': ['Device: endovascular coiling with any type of currently approved coil (first or second generation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'coiling plus stenting', 'description': 'endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.', 'interventionNames': ['Device: endovascular coiling with any type of currently approved coil (first or second generation)', 'Device: endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.']}], 'interventions': [{'name': 'endovascular coiling with any type of currently approved coil (first or second generation)', 'type': 'DEVICE', 'description': 'Standard procedure for endovascular coiling.Coils may be bare Platinum coils or any so-called second generation coils such as but not restricted to Hydrocoil or Cerecyte', 'armGroupLabels': ['coiling', 'coiling plus stenting']}, {'name': 'endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.', 'type': 'DEVICE', 'description': 'Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician', 'armGroupLabels': ['coiling plus stenting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '29 609 Brest', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest (Brest University Hospital)', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Jean Raymond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Brest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}