Intracerebral Aneursym Clinical Trial
— HCATOfficial title:
HydroCoil Cerebral Aneurysm Treatment Trial
| Verified date | December 2014 |
| Source | University of Virginia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
| Status | Terminated |
| Enrollment | 215 |
| Est. completion date | June 2015 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 90 Years |
| Eligibility |
Inclusion Criteria: 1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist) 2. The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel. 3. Patients between (and including) 21 and 90 years of age. 4. Patient HUNT AND HESS Grade 0-3. 5. Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney. 6. Aneurysm 5-20mm in maximum diameter. 7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment. 8. The patient has not been previously randomized into this or another related ongoing trial. 9. The aneurysm has not previously been treated (by coiling or clipping). Exclusion Criteria: 1. 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). 2. Target aneurysm has had previous coil treatment or surgically clipped. 3. Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH). 4. Inability to obtain informed consent. 5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mercy Stroke Center | Carmichael | California |
| United States | Medical college of South Carolina | Charleston | South Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | University of Texas Southwest Medical Center | Dallas | Texas |
| United States | University of Florida | Gainesville | Florida |
| United States | The Methodist Research Institute | Houston | Texas |
| United States | University of Southern California | Los Angeles | California |
| United States | St. Luke's/Roosevelt Hospital Center | New York | New York |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Saint Louis University | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| University of Virginia | Microvention-Terumo, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Treatment related morbidity and mortality | Treatment related morbidity and mortality, as measured by the NIH stroke scale; | 12-18 months | |
| Secondary | Packing density | Packing density as measured by volumetric filling of the aneurysm. | 12-18 months | |
| Secondary | Clinical outcome | Clinical outcome as measured by Modified Rankin Scale | 6 months | |
| Secondary | Clinical Outcome | Clinical outcome as measured by the Modified Rankin scale | 12-18 months | |
| Secondary | Re-bleed rates | Comparison of rebleed rates at 12-18 months | 12-18 months | |
| Secondary | Re-treatment rates | Comparison of re-treatment rates at 12-18 months post treatment. | 12-18 months | |
| Secondary | Cost of treatment | Comparison of cost of treatment. | 12-18 months |