Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-06 @ 12:30 AM
Study NCT ID:
NCT02948504
Status:
UNKNOWN
Last Update Posted:
2016-11-15
First Post:
2016-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Small Intracranial Aneurysm Study (CSIAS)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedural complications', 'timeFrame': '30 days after coiling or clipping'}], 'primaryOutcomes': [{'measure': 'Rupture of an unruptured aneurysm', 'timeFrame': 'One year of follow-up', 'description': 'These aneurysms are left untreated.'}], 'secondaryOutcomes': [{'measure': 'Regrowth of an unruptured aneurysm', 'timeFrame': '9 and 12 months of imaging follow-up'}, {'measure': 'Recurrence and retreatment after coiling or clipping', 'timeFrame': 'one year of follow-up'}, {'measure': 'Poor outcome after coiling or clipping', 'timeFrame': '6 and 12 months', 'description': 'Poor outcome is defined as a mRS 3-6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Unruptured Intracranial Aneurysm', 'Small aneurysms', 'Risk of rupture', 'Natural history', 'Endovascular Coiling', 'Surgical clipping'], 'conditions': ['Intracranial Aneurysm', 'Unruptured Cerebral Aneurysm', 'Treatment Side Effects']}, 'referencesModule': {'references': [{'pmid': '20671254', 'type': 'BACKGROUND', 'citation': 'Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.'}, {'pmid': '20378866', 'type': 'BACKGROUND', 'citation': 'Rahman M, Smietana J, Hauck E, Hoh B, Hopkins N, Siddiqui A, Levy EI, Meng H, Mocco J. Size ratio correlates with intracranial aneurysm rupture status: a prospective study. Stroke. 2010 May;41(5):916-20. doi: 10.1161/STROKEAHA.109.574244. Epub 2010 Apr 8.'}, {'pmid': '24290159', 'type': 'BACKGROUND', 'citation': 'Greving JP, Wermer MJ, Brown RD Jr, Morita A, Juvela S, Yonekura M, Ishibashi T, Torner JC, Nakayama T, Rinkel GJ, Algra A. Development of the PHASES score for prediction of risk of rupture of intracranial aneurysms: a pooled analysis of six prospective cohort studies. Lancet Neurol. 2014 Jan;13(1):59-66. doi: 10.1016/S1474-4422(13)70263-1. Epub 2013 Nov 27.'}, {'pmid': '24646873', 'type': 'BACKGROUND', 'citation': 'Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.'}, {'pmid': '23868274', 'type': 'BACKGROUND', 'citation': 'Juvela S, Poussa K, Lehto H, Porras M. Natural history of unruptured intracranial aneurysms: a long-term follow-up study. Stroke. 2013 Sep;44(9):2414-21. doi: 10.1161/STROKEAHA.113.001838. Epub 2013 Jul 18.'}, {'pmid': '24003049', 'type': 'BACKGROUND', 'citation': 'Guresir E, Vatter H, Schuss P, Platz J, Konczalla J, de Rochement Rdu M, Berkefeld J, Seifert V. Natural history of small unruptured anterior circulation aneurysms: a prospective cohort study. Stroke. 2013 Nov;44(11):3027-31. doi: 10.1161/STROKEAHA.113.001107. Epub 2013 Sep 3.'}, {'pmid': '22738097', 'type': 'BACKGROUND', 'citation': 'UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.'}, {'pmid': '25753954', 'type': 'BACKGROUND', 'citation': 'Tominari S, Morita A, Ishibashi T, Yamazaki T, Takao H, Murayama Y, Sonobe M, Yonekura M, Saito N, Shiokawa Y, Date I, Tominaga T, Nozaki K, Houkin K, Miyamoto S, Kirino T, Hashi K, Nakayama T; Unruptured Cerebral Aneurysm Study Japan Investigators. Prediction model for 3-year rupture risk of unruptured cerebral aneurysms in Japanese patients. Ann Neurol. 2015 Jun;77(6):1050-9. doi: 10.1002/ana.24400. Epub 2015 Apr 22.'}, {'pmid': '26742803', 'type': 'BACKGROUND', 'citation': 'Murayama Y, Takao H, Ishibashi T, Saguchi T, Ebara M, Yuki I, Arakawa H, Irie K, Urashima M, Molyneux AJ. Risk Analysis of Unruptured Intracranial Aneurysms: Prospective 10-Year Cohort Study. Stroke. 2016 Feb;47(2):365-71. doi: 10.1161/STROKEAHA.115.010698. Epub 2016 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'Intracranial aneurysms are common in the general population. The overall prevalence of unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than before, UIAs are increasingly being detected. Most patients with small aneurysms (less than 5mm) are incidentally found in clinical practice. Some studies indicate that the majority of patients with UIAs, particularly with small aneurysms (\\<7mm), have a low risk of rupture, and others have found that small ruptured aneurysms have a high proportion in patients with SAH. Therefore, there is a lot of controversy regarding which small aneurysms can be left untreated, or which aneurysms are needed to be treated with clipping or coiling.\n\nThe prevalence varies widely among different detection methods, race/ethnicity or patients with other inherited diseases. Although a wealth of data is available for the natural history of UIAs, the true natural history remains unknown because case selection bias occur in almost all studies. However, data on Chinese UIA is unknown. Using the MR angiography (MRA) to detect aneurysms, the prevalence is 7% of selected adult population in China. Therefore, small UIAs are very common and are increasingly being detected in clinical practice. Conservative treatment, surgical clipping and endovascular coiling are the three treatment options for UIAs. The optimal treatment remains controversial, particularly for small aneurysms (less than 7mm). To date, no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for UIAs. It may be impossible to conduct the randomized controlled study considering aneurysm ruptured as a devastating event. However, surgical clipping or endovascular treatment itself carries a risk of immediate morbidity or mortality. Therefore, a substantial variability widely exists in treatment decision-making for UIAs, and this may lead to a great variability in clinical recommendations.\n\nOur study is a prospective observational study to identify the incidence of rupture of small aneurysms in the first year after the diagnosis of the aneurysm which is left untreated. Meanwhile, we determine the differences of outcomes, procedural complications, and rates of retreatment between surgical clipping and endovascular coiling for small UIAs in China.', 'detailedDescription': '1. Background: There is a lot of controversy regarding which aneurysms can be left untreated, or which aneurysms are needed to be treated with clipping or coiling. To date, no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for small UIAs.\n2. Study design: A multicenter prospective observation registry study. This study is undertaken to conform to the study protocol. Patients will be recruited between December 2016 and December 2018. Patients are eligible for the study if they meet the inclusion criteria and they are not eligible if any of the following exclusion criteria are met.\n3. Procedures: All patients were interviewed by a multidisciplinary team that consisted of vascular neurosurgeons, interventional neuroradiologists and anesthetists. If patients meet all of the inclusion criteria: an unruptured aneurysms ≤5mm are enrolled and then followed up at 6 and12 months. Clinical observation, surgical clipping and endovascular coiling are the three treatment options for UIAs. In general, when an UIA is detected, it should be needed to quit smoking, to aggressively manage hypertension, and to control alcohol use. When an aggressive treatment is considered, treatment risks should be balanced against the risk of rupture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Five hundred patients with unruptured aneurysms will registered in this study during the 3 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Intracranial unruptured aneurysms confirmed by digital subtraction angiography DSA, CT angiography or MR angiography (MRA);\n2. The maximum size of unruptured aneurysm ≤5mm;\n3. Informed consent\n\nExclusion Criteria:\n\n1.Patients with severe systemic disorders and expected life span less than one year; 2.Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT02948504', 'briefTitle': 'Chinese Small Intracranial Aneurysm Study (CSIAS)', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Treatment of Small Unruptured Intracranial Aneurysms Based on Clinical Characteristics, Morphology and Hemodynamic Features', 'orgStudyIdInfo': {'id': 'RJ2016144K1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': "Aneurysms are left untreated based on patients and family's wishes. These patients will be included in the observation group."}, {'label': 'Coiling or Clipping', 'description': 'Patients are included in the coiling group if they undergo endovascular coiling, such as single coiling, stent-assisted coiling and balloon-assisted coiling. Or Patients are included in the clipping group if they undergo surgical coiling, such as aneurysm neck clipping, aneurysm isolation or trapping.', 'interventionNames': ['Procedure: Coiling or Clipping']}], 'interventions': [{'name': 'Coiling or Clipping', 'type': 'PROCEDURE', 'description': 'All patients are treated under general anesthesia and systemic heparinization. A bolus of 50-75 IU/kg of heparin is given after femoral sheath placement, and intermittent boluses of 1250 IU per hour are given during the procedure. Activated clotting time is maintained at 2-3 times baseline level. Balloon-assisted coiling or stent-assisted coiling are considered in aneurysms with an unfavorable morphology (aneurysm neck≥ 4.0 mm or dome/neck ≤2.0). All anterior circulation aneurysms are clipped through a standard pterional or frontal temporal approach. The posterior circulation aneurysms are treated using far lateral approach depending on the aneurysm location.', 'armGroupLabels': ['Coiling or Clipping']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bing Zhao', 'role': 'CONTACT', 'email': 'drzhaobing@yahoo.com', 'phone': '08613601696475'}], 'overallOfficials': [{'name': 'Jieqing Wan, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}