Trial record 4 of 145 for:
Cerebral Aneurysms
HydroCoil Cerebral Aneurysm Treatment Trial (HCAT)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Virginia
Collaborator:
Microvention-Terumo, Inc.
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01195129
First received: September 2, 2010
Last updated: August 25, 2011
Last verified: August 2011
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Purpose
The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Aneursym |
Device: MicroVention Hydrogel coil Device: Non-hydrogel coils |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | HydroCoil Cerebral Aneurysm Treatment Trial |
Resource links provided by NLM:
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- Occlusion rate [ Time Frame: 12 - 18 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Treatment related morbidity and mortality [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]Treatment related morbidity and mortality, as measured by the NIH stroke scale;
- Packing density [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]Packing density as measured by volumetric filling of the aneurysm.
- Clinical outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]Clinical outcome as measured by Modified Rankin Scale
- Clinical Outcome [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]Clinical outcome as measured by the Modified Rankin scale
- Re-bleed rates [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]Comparison of rebleed rates at 12-18 months
- Re-treatment rates [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]Comparison of re-treatment rates at 12-18 months post treatment.
- Cost of treatment [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]Comparison of cost of treatment.
| Estimated Enrollment: | 799 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MicroVention Hydrogel Coils
FDA approved and in common use for cerebral aneurysm treatment.
|
Device: MicroVention Hydrogel coil
Micro Vention Hydrogel Coils
|
|
Active Comparator: Non-hydrogel coil
Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm).
|
Device: Non-hydrogel coils
Cerecyte or bare platinum coils
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
- The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel.
- Patients between (and including) 21 and 90 years of age.
- Patient HUNT AND HESS Grade 0-3.
- 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.
- Aneurysm 5-20mm in maximum diameter.
- 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.
- The patient has not been previously randomized into this or another related ongoing trial.
- The aneurysm has not previously been treated (by coiling or clipping).
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.
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195129
Locations
| United States, California | |
| Mercy Stroke Center | |
| Carmichael, California, United States | |
| University of Southern California | |
| Los Angeles, California, United States | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States | |
| United States, Missouri | |
| Saint Louis University | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| St. Luke's/Roosevelt Hospital Center | |
| New York, New York, United States | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States | |
| United States, South Carolina | |
| Medical college of South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Texas | |
| University of Texas Southwest Medical Center | |
| Dallas, Texas, United States | |
| The Methodist Research Institute | |
| Houston, Texas, United States | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States | |
Sponsors and Collaborators
University of Virginia
Microvention-Terumo, Inc.
Investigators
| Principal Investigator: | Avery J Evans, MD | University of Virginia |
More Information
No publications provided
| Responsible Party: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01195129 History of Changes |
| Other Study ID Numbers: | 13861 |
| Study First Received: | September 2, 2010 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
Stent cerebral aneursym neurology radiology |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013