Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEB Aneurysm Embolization Device | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB | Device | Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device |
| Measure | Description | Time Frame |
|---|---|---|
| Key Effectiveness Outcome | Proportion of subjects with adequate aneurysm occlusion at one year after treatment. | 12 Months |
| Key Safety Outcome | 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 | 12 Months |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Fiorella, MD | Stony Brook University, Stony Brook NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Health Systems | Hollywood | Florida | 33021 | United States | ||
| Orlando Health Neuroscience Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando |
| Florida |
| 32806 |
| United States |
| The Queen's Medical Center Neuroscience Institute | Honolulu | Hawaii | 96813 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Health System | Kansas City | Kansas | 66160 | United States |
| Baptist Health Systems | Lexington | Kentucky | 40503 | United States |
| University of Kentucky, Department of Neurosurgery | Lexington | Kentucky | 40536 | United States |
| Norton Healthcare | Louisville | Kentucky | 40241 | United States |
| LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | 71103 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Brigham Incorporated | Boston | Massachusetts | 02114 | United States |
| UMass Memorial Health | Worcester | Massachusetts | 01655 | United States |
| Abbott Northwestern Hospital Allina Health | Minneapolis | Minnesota | 55407 | United States |
| The Washington University | St Louis | Missouri | 63110 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| Northshore University Hospital/Northwell Health | Manhasset | New York | 11030 | United States |
| SUNY Stony Brook | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| The Toledo Hospital d/b/a ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania Health Systems | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Semmes Murphey | Memphis | Tennessee | 38120 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided