HydroCoil Cerebral Aneurysm Treatment Trial (HCAT)

This study has been terminated.
(Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling and will provide results based on the recruited subjects.)
Sponsor:
Collaborator:
Microvention-Terumo, Inc.
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01195129
First received: September 2, 2010
Last updated: July 1, 2013
Last verified: July 2013

September 2, 2010
July 1, 2013
December 2008
April 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01195129 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
HydroCoil Cerebral Aneurysm Treatment Trial
HydroCoil Cerebral Aneurysm Treatment Trial

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Aneursym
  • Device: MicroVention Hydrogel coil
    Micro Vention Hydrogel Coils
  • Device: Non-hydrogel coils
    Cerecyte or bare platinum coils
  • MicroVention Hydrogel Coils
    FDA approved and in common use for cerebral aneurysm treatment.
    Intervention: Device: MicroVention Hydrogel coil
  • Active Comparator: Non-hydrogel coil
    Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm).
    Intervention: Device: Non-hydrogel coils
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
215
December 2013
April 2013   (final data collection date for primary outcome measure)

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.

    -

Both
21 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01195129
13861
Yes
University of Virginia
University of Virginia
Microvention-Terumo, Inc.
Principal Investigator: Avery J Evans, MD University of Virginia
University of Virginia
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP