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| Name | Class |
|---|---|
| Stryker Neurovascular | INDUSTRY |
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This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter).
Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.
Primary Study Objective: Occlusion rate: angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization.
Secondary Objectives:
Study Design: FEAT will be a prospective, randomized trial comparing the utilization of 0.014-0.0155" coils versus smaller diameter coils in mid-sized aneurysm treatment. The 0.014-0.0155" bare platinum coils (Stryker, Natick, MA) are FDA-approved and in common use at institutions in this country and across the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to either the framing coil treatment or the non-framing coil treatment. Data on each patient will be collected at the time of enrollment and treatment, and at first and second follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eighteen Coils (0.014-0.0155 inch) | Active Comparator | Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils. |
|
| Standard Coils (0.014 inch) | Active Comparator | Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coil Embolization with larger Diameter Coils | Procedure | Eighteen Coils placed in cerebral aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion Rate | Occlusion rate: Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization. | 12-18 Month Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure. | Entire Study Duration (from signed research consent until 12-18 month follow-up complete) |
| Packing Density |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J D Mocco, MD, MS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF-Fresno, Community Regional Medical Center | Fresno | California | 93701 | United States | ||
| Radiology Imaging Associates |
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| Label | URL |
|---|---|
| Vanderbilt University Medical Center-Department of Neurological Surgery | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2024 |
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| Coil Embolization with Standard Diameter Coils | Procedure | Cerebral aneurysms will be embolized with standard diameter coils. |
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Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
| Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed) |
| Clinical Outcome | Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale. | 3-6 Month Follow-up and 12-18 Month Follow-up |
| Re-hemorrhage and Re-treatment Rates | Re-hemorrhage rates will be tracked and recorded during both follow-up time points. | 3-6 Month Follow-up and 12-18 Month Follow-up |
| Mortality | Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment. | Entire Study Duration (from study procedure until 12-18 month follow-up) |
| Retreatment | Retreatment rates will be tracked and recorded during both follow-up time points. | 3-6 Month Follow-up and 12-18 Month Follow-up |
| Englewood |
| Colorado |
| 80112 |
| United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| University of South Florida - Tampa General | Tampa | Florida | 33606 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Massachusetts Medical School | North Worcester | Massachusetts | 01655 | United States |
| University of Mississippi | Jackson | Mississippi | 39216 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Mayfield Clinic | Cincinnati | Ohio | 45219 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Medical Center of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health | Greenville | South Carolina | 29615 | United States |
| Tennessee Interventional Associates - Erlanger | Chattanooga | Tennessee | 37403 | United States |
| Fort Sanders Regional Medical Center | Knoxville | Tennessee | 37916 | United States |
| University of Tennessee Medical Center - Knoxville | Knoxville | Tennessee | 37920 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| University of Texas - Southwestern | Dallas | Texas | 75390 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| May 8, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2020 | May 7, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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