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
  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.


Enrollment: 215
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: April 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:

  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.

    -

  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: July 1, 2013
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 April 17, 2014