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Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling.
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| Name | Class |
|---|---|
| Microvention-Terumo, Inc. | INDUSTRY |
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The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroVention Hydrogel Coils | Other | FDA approved and in common use for cerebral aneurysm treatment. |
|
| Non-hydrogel coils | Active Comparator | Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroVention Hydrogel coil | Device | Micro Vention Hydrogel Coils |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 treatment. | 12 - 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related morbidity and mortality | Treatment related morbidity and mortality, as measured by the NIH stroke scale; | 12-18 months |
| Packing density | Packing density as measured by volumetric filling of the aneurysm. |
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Inclusion Criteria:
Exclusion Criteria:
Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).
Target aneurysm has had previous coil treatment or surgically clipped.
Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
Inability to obtain informed consent.
Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.
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| Name | Affiliation | Role |
|---|---|---|
| Avery J Evans, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Stroke Center | Carmichael | California | United States | |||
| University of Southern California |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 24, 2017 | |
| Reset | Jun 20, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 24, 2017 | Jun 20, 2017 |
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| Non-hydrogel coils |
| Device |
Cerecyte or bare platinum coils |
|
| 12-18 months |
| Clinical outcome | Clinical outcome as measured by Modified Rankin Scale | 6 months |
| Clinical Outcome | Clinical outcome as measured by the Modified Rankin scale | 12-18 months |
| Re-bleed rates | Comparison of rebleed rates at 12-18 months | 12-18 months |
| Re-treatment rates | Comparison of re-treatment rates at 12-18 months post treatment. | 12-18 months |
| Cost of treatment | Comparison of cost of treatment. | 12-18 months |
| Los Angeles |
| California |
| United States |
| University of Florida | Gainesville | Florida | United States |
| Saint Louis University | St Louis | Missouri | United States |
| St. Luke's/Roosevelt Hospital Center | New York | New York | United States |
| Oregon Health and Science University | Portland | Oregon | United States |
| Medical college of South Carolina | Charleston | South Carolina | United States |
| University of Texas Southwest Medical Center | Dallas | Texas | United States |
| The Methodist Research Institute | Houston | Texas | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | United States |