HydroCoil Cerebral Aneurysm Treatment Trial

Stopped early · Phase 4

Conditions studied: Intracerebral Aneursym

In brief

The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.

Key facts

Study ID

NCT01195129

Run by

University of Virginia

People needed

215

Starts

2008-12-01

Expected to finish

2015-06-01

Last updated by the study team

2014-12-12

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Mercy Stroke Center — Carmichael, California, United States
• University of Southern California — 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, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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