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HydroCoil Cerebral Aneurysm Treatment Trial (HCAT)

Primary Purpose

Intracerebral Aneursym

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MicroVention Hydrogel coil
Non-hydrogel coils
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Aneursym focused on measuring Stent, cerebral aneursym, neurology, radiology

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Mercy Stroke Center
  • University of Southern California
  • University of Florida
  • Saint Louis University
  • St. Luke's/Roosevelt Hospital Center
  • Oregon Health and Science University
  • Medical college of South Carolina
  • University of Texas Southwest Medical Center
  • The Methodist Research Institute
  • University of Virginia
  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

MicroVention Hydrogel Coils

Non-hydrogel coils

Arm Description

FDA approved and in common use for cerebral aneurysm treatment.

Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm).

Outcomes

Primary Outcome Measures

Occlusion rate
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
Treatment related morbidity and mortality, as measured by the NIH stroke scale;
Packing density
Packing density as measured by volumetric filling of the aneurysm.
Clinical outcome
Clinical outcome as measured by Modified Rankin Scale
Clinical Outcome
Clinical outcome as measured by the Modified Rankin scale
Re-bleed rates
Comparison of rebleed rates at 12-18 months
Re-treatment rates
Comparison of re-treatment rates at 12-18 months post treatment.
Cost of treatment
Comparison of cost of treatment.

Full Information

First Posted
September 2, 2010
Last Updated
December 11, 2014
Sponsor
University of Virginia
Collaborators
Microvention-Terumo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01195129
Brief Title
HydroCoil Cerebral Aneurysm Treatment Trial
Acronym
HCAT
Official Title
HydroCoil Cerebral Aneurysm Treatment Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling.
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
Collaborators
Microvention-Terumo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Aneursym
Keywords
Stent, cerebral aneursym, neurology, radiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MicroVention Hydrogel Coils
Arm Type
Other
Arm Description
FDA approved and in common use for cerebral aneurysm treatment.
Arm Title
Non-hydrogel coils
Arm Type
Active Comparator
Arm Description
Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm).
Intervention Type
Device
Intervention Name(s)
MicroVention Hydrogel coil
Intervention Description
Micro Vention Hydrogel Coils
Intervention Type
Device
Intervention Name(s)
Non-hydrogel coils
Intervention Description
Cerecyte or bare platinum coils
Primary Outcome Measure Information:
Title
Occlusion rate
Description
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.
Time Frame
12 - 18 months
Secondary Outcome Measure Information:
Title
Treatment related morbidity and mortality
Description
Treatment related morbidity and mortality, as measured by the NIH stroke scale;
Time Frame
12-18 months
Title
Packing density
Description
Packing density as measured by volumetric filling of the aneurysm.
Time Frame
12-18 months
Title
Clinical outcome
Description
Clinical outcome as measured by Modified Rankin Scale
Time Frame
6 months
Title
Clinical Outcome
Description
Clinical outcome as measured by the Modified Rankin scale
Time Frame
12-18 months
Title
Re-bleed rates
Description
Comparison of rebleed rates at 12-18 months
Time Frame
12-18 months
Title
Re-treatment rates
Description
Comparison of re-treatment rates at 12-18 months post treatment.
Time Frame
12-18 months
Title
Cost of treatment
Description
Comparison of cost of treatment.
Time Frame
12-18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avery J Evans, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Stroke Center
City
Carmichael
State/Province
California
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
St. Luke's/Roosevelt Hospital Center
City
New York
State/Province
New York
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Medical college of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
University of Texas Southwest Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
The Methodist Research Institute
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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HydroCoil Cerebral Aneurysm Treatment Trial

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