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The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEB Aneurysm Embolization Device | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB | Device | The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365. | The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment. | 12 months |
| Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment | The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment in the mITT population. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Arthur, MD | Methodist University Hospital, Memphis, TN | Principal Investigator |
| David Fiorella, MD | Stony Brook University, Stony Brook, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Sequent Medical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30992395 | Derived | Arthur AS, Molyneux A, Coon AL, Saatci I, Szikora I, Baltacioglu F, Sultan A, Hoit D, Delgado Almandoz JE, Elijovich L, Cekirge S, Byrne JV, Fiorella D; WEB-IT Study investigators. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. J Neurointerv Surg. 2019 Sep;11(9):924-930. doi: 10.1136/neurintsurg-2019-014815. Epub 2019 Apr 16. | |
| 28096478 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 12, 2015 | Apr 7, 2020 |
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| Aliso Viejo |
| California |
| 92565 |
| United States |
| Radiology Imaging Associates P.C. | Englewood | Colorado | 80112 | United States |
| Lyerly Baptist, Inc | Jacksonville | Florida | 32207 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 021115 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Buffalo General Medical Center | Buffalo | New York | 14203 | United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Carolina NeuroSurgery & Spine Associates, P.A. | Charlotte | North Carolina | 28204 | United States |
| Riverside Methodist Hospital/ Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Ft. Sanders Regional Medical Center | Knoxville | Tennessee | 37916 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | United States |
| West Virginia University | Morgantown | West Virginia | 26505 | United States |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Helios Hospital | Erfurt | 99028 | Germany |
| National Institute of Neurosciences | Budapest | 1145 | Hungary |
| Koru Hospital | Ankara | Turkey (Türkiye) |
| Marmara University Faculty of Medicine Pendik Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| Derived |
| Fiorella D, Molyneux A, Coon A, Szikora I, Saatci I, Baltacioglu F, Sultan A, Arthur A; WEB-IT Study Investigators. Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT). J Neurointerv Surg. 2017 Dec;9(12):1191-1196. doi: 10.1136/neurintsurg-2016-012841. Epub 2017 Jan 17. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Race and Ethnicity were not obtained for subjects from the European and Canadian sites. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365. | The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment. | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment | The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment in the mITT population. | The overall number of participants analyzed is 143 due to 3 subjects withdrawing and 4 subjects that missed their 1 year follow up visit. | Posted | Count of Participants | Participants | 12 months |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CEC Adjudicated Adverse Events Through 1-Year | 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. | 0 | 150 | 33 | 150 | 54 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Cushing's syndrome | Endocrine disorders | Systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cytomegalovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood pressure increased | Investigations | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Aphasia | Nervous system disorders | Systematic Assessment |
| ||
| Benign intracranial hypertension | Nervous system disorders | Systematic Assessment |
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| Confusional state | Nervous system disorders | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Ischemic Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Subarachnoid hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
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| TIA | Nervous system disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vessel puncture site hematoma | Surgical and medical procedures | Systematic Assessment |
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| Arterial thrombosis | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Vascular occlusion | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vessel puncture site hematoma | Vascular disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Adverse drug reaction | General disorders | Systematic Assessment |
| ||
| Visual impairment | Eye disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Sequent Medical, Inc | 714-247-8000 | anne.hurley@microvention.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2015 | Apr 7, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| Canada |
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| Denmark |
|
| Germany |
|
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