Clinical trial NCT01195129: HydroCoil Cerebral Aneurysm Treatment Trial
Official title: HydroCoil Cerebral Aneurysm Treatment Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Intracerebral Aneursym
Keywords: Stent
cerebral aneursym
neurology
radiology
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Microvention-Terumo, Inc.
First posted: 2010-09-03
Enrollment: 215
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: 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.

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Primary outcomes:
measure: Occlusion rate
timeFrame: 12 - 18 months
Secondary outcomes:
measure: Treatment related morbidity and mortality
timeFrame: 12-18 months
measure: Packing density
timeFrame: 12-18 months
measure: Clinical outcome
timeFrame: 6 months
measure: Clinical Outcome
timeFrame: 12-18 months
measure: Re-bleed rates
timeFrame: 12-18 months
measure: Re-treatment rates
timeFrame: 12-18 months
measure: Cost of treatment
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Carmichael
country: United States
facility: Mercy Stroke Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: New York
country: United States
facility: St. Luke's/Roosevelt Hospital Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Medical college of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwest Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: University of Virginia
name: Avery J Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: