Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04839705
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2021-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Key Effectiveness Outcome', 'timeFrame': '12 Months', 'description': 'Proportion of subjects with adequate aneurysm occlusion at one year after treatment.'}, {'measure': 'Key Safety Outcome', 'timeFrame': '12 Months', 'description': 'Proportion of subjects with death of any nonaccidental cause or any major stroke\\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Aneurysm', 'Intracranial Arterial Disease', 'Cerebrovascular Disorders'], 'conditions': ['Wide Neck Bifurcation Intracranial Aneurysms']}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Patient must be ≥ 18 at the time of screening\n* Patient must have a single ruptured or unruptured IA requiring treatment\n* Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures\n\nKey Exclusion Criteria:\n\n* Patient has an IA with characteristics unsuitable for endovascular treatment\n* Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days\n* Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days\n* Patient index IA was previously treated\n* Patient is pregnant'}, 'identificationModule': {'nctId': 'NCT04839705', 'acronym': 'WEB PAS', 'briefTitle': 'Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Microvention-Terumo, Inc.'}, 'officialTitle': 'Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device', 'orgStudyIdInfo': {'id': 'CL11010-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'WEB Aneurysm Embolization Device', 'description': 'WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.', 'interventionNames': ['Device: WEB']}], 'interventions': [{'name': 'WEB', 'type': 'DEVICE', 'description': 'Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.\n\nOther Names:\n\n• WEB Aneurysm Embolization Device', 'armGroupLabels': ['WEB Aneurysm Embolization Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Piret Baldwin', 'role': 'CONTACT', 'email': 'pibaldwin@mhs.net', 'phone': '954-558-1194'}, {'name': 'Brijesh Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Health Systems', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charlene Carlo', 'role': 'CONTACT', 'email': 'charlene.carlo@orlandohealth.com', 'phone': '407-739-0982'}, {'name': 'Jay Vachhani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando Health Neuroscience Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Diedrich', 'role': 'CONTACT', 'email': 'KDiedrich@Queens.org', 'phone': '808-691-4428'}, {'name': 'Yi Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Queen's Medical Center Neuroscience Institute", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Connor Aamot', 'role': 'CONTACT', 'email': 'connor-aamot@uiowa.edu', 'phone': '360-483-9477'}, {'name': 'Edgar Samaniego, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Max Hardenbrook', 'role': 'CONTACT', 'email': 'mhardenbrook@kumc.edu', 'phone': '913-588-6191'}, {'name': 'Koji Ebersole, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Health System', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Candice Brunton', 'role': 'CONTACT', 'email': 'Candice.Brunton@bhsi.com', 'phone': '502-708-9791'}, {'name': 'Richard Paulsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Health Systems', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Norris', 'role': 'CONTACT', 'email': 'rachel.norris@uky.edu', 'phone': '859-218-1644'}, {'name': 'David Dornbos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky, Department of Neurosurgery', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Trina DeForrest', 'role': 'CONTACT', 'email': 'Trina.Deforrest@nortonhealthcare.org', 'phone': '502-446-8991'}, {'name': 'Tom Yao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tracy Norwood', 'role': 'CONTACT', 'email': 'tnorwo@lushsc.edu', 'phone': '318-675-5521'}, {'name': 'Hugo Cuellar-Saenz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LSU Health Sciences Center at Shreveport', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlyn Henry', 'role': 'CONTACT', 'email': 'KHenry@som.umaryland.edu', 'phone': '410-328-0939'}, {'name': 'Timothy Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Maryland, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Whitney Isennock', 'role': 'CONTACT', 'email': 'wwebb10@jhmi.edu', 'phone': '443-262-1657'}, {'name': 'Justin Caplan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Austin Birmingham', 'role': 'CONTACT', 'email': 'ABIRMINGHAM@mgh.harvard.edu', 'phone': '(845) 500-1694'}, {'name': 'Robert Regenhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Brigham Incorporated', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Noelle Bodkin', 'role': 'CONTACT', 'email': 'Noelle.bodkin@umassmed.edu', 'phone': '508-856-2067'}, {'name': 'Jasmeet Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UMass Memorial Health', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nimco Essa', 'role': 'CONTACT', 'email': 'nimco.essa@allina.com', 'phone': '614-806-5484'}, {'name': 'Yasha Kayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abbott Northwestern Hospital Allina Health', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ramie Heo', 'role': 'CONTACT', 'email': 'heor@wustl.edu', 'phone': '314-747-4569'}, {'name': 'Ananth Vellimana, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tuba Ahmed', 'role': 'CONTACT', 'email': 'ahmedt4@amc.edu', 'phone': '518-262-5868'}, {'name': 'Alexandra Paul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gianna Coscia', 'role': 'CONTACT', 'email': 'gcosia@ubns.com', 'phone': '716-545-5300'}, {'name': 'Adnan Siddiqui, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ali Imran', 'role': 'CONTACT', 'email': 'aimran5@northwell.edu', 'phone': '516-253-7753'}, {'name': 'Timothy White, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northshore University Hospital/Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dawn Madigan', 'role': 'CONTACT', 'email': 'Dawn.Madigan@stonybrookmedicine.edu', 'phone': '631-444-8121'}, {'name': 'David Fiorella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SUNY Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lavinia Williams', 'role': 'CONTACT', 'email': 'lavwilliam@montefiore.org', 'phone': '718-502-0552'}, {'name': 'David Altschul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amayrani Calvario Salgado', 'role': 'CONTACT', 'email': 'Amayrani.calvariosalgado@duke.edu', 'phone': '919-681-8585'}, {'name': 'Erik Hauck, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Frost', 'role': 'CONTACT', 'email': 'megan.frost@osumc.edu', 'phone': '567-525-6824'}, {'name': 'Patrick Youssef, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Bartelt', 'role': 'CONTACT', 'email': 'heather.bartelt@ohiohealth.com', 'phone': '614-788-3863'}, {'name': 'Ronald Budzik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OhioHealth Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diane Philip', 'role': 'CONTACT', 'email': 'Diane.Philip@promedica.org', 'phone': '419-291-1360'}, {'name': 'Mouhammad Jumaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Toledo Hospital d/b/a ProMedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Omini', 'role': 'CONTACT', 'email': 'michael-omini@ouhsc.edu', 'phone': '785-979-6704'}, {'name': 'Hakeem Shakir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Denney', 'role': 'CONTACT', 'email': 'nicole.denney@pennmedicine.upenn.edu', 'phone': '801-831-1044'}, {'name': 'Jan-Karl Burkhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania Health Systems', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendell Gaskins', 'role': 'CONTACT', 'email': 'Wendell.Gaskins@Jefferson.edu', 'phone': '215-503-5646'}, {'name': 'Pascal Jabbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendell Barnett', 'role': 'CONTACT', 'email': 'wbarnett@semmes-murphey.com', 'phone': '662-804-9800'}, {'name': 'Daniel Hoit, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Semmes Murphey', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Domico', 'role': 'CONTACT', 'email': 'jennifer.domico@wvumedicine.org', 'phone': '304-293-7012'}, {'name': 'Sohyun Boo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Amy Bowles', 'role': 'CONTACT', 'email': 'amy.bowles@microvention.com', 'phone': '714-482-8074'}], 'overallOfficials': [{'name': 'Adam Arthur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist University Hospital, Memphis TN'}, {'name': 'David Fiorella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University, Stony Brook NY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Microvention-Terumo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}