Status:
TERMINATED
HydroCoil Cerebral Aneurysm Treatment Trial
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Microvention-Terumo, Inc.
Conditions:
Intracerebral Aneursym
Eligibility:
All Genders
21-90 years
Phase:
PHASE4
Brief Summary
The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT01195129
Start Date
December 1 2008
End Date
June 1 2015
Last Update
December 12 2014
Active Locations (11)
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1
Mercy Stroke Center
Carmichael, California, United States
2
University of Southern California
Los Angeles, California, United States
3
University of Florida
Gainesville, Florida, United States
4
Saint Louis University
St Louis, Missouri, United States