HydroCoil Cerebral Aneurysm Treatment Trial (HCAT)

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

Study Overview

• Status: Terminated
• Conditions: Intracerebral Aneursym
• Intervention / Treatment: Device: MicroVention Hydrogel coil; Device: Non-hydrogel 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.

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Carmichael, California, United States
      • Mercy Stroke Center
    • Los Angeles, California, United States
      • University of Southern California
  • Florida
    • Gainesville, Florida, United States
      • University of Florida
  • Missouri
    • St. Louis, Missouri, United States
      • Saint Louis University
  • New York
    • New York, New York, United States
      • St. Luke's/Roosevelt Hospital Center
  • Oregon
    • Portland, Oregon, United States
      • Oregon Health and Science University
  • South Carolina
    • Charleston, South Carolina, United States
      • Medical College of South Carolina
  • Texas
    • Dallas, Texas, United States
      • University of Texas Southwest Medical Center
    • Houston, Texas, United States
      • The Methodist Research Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Norfolk, Virginia, United States
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 coils; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 - 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related morbidity and mortality	Treatment related morbidity and mortality, as measured by the NIH stroke scale;	12-18 months
Packing density	Packing density as measured by volumetric filling of the aneurysm.	12-18 months
Clinical outcome	Clinical outcome as measured by Modified Rankin Scale	6 months
Clinical Outcome	Clinical outcome as measured by the Modified Rankin scale	12-18 months
Re-bleed rates	Comparison of rebleed rates at 12-18 months	12-18 months
Re-treatment rates	Comparison of re-treatment rates at 12-18 months post treatment.	12-18 months
Cost of treatment	Comparison of cost of treatment.	12-18 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Microvention-Terumo, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2013
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 2, 2010
• First Posted (Estimate): September 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Stent; neurology; radiology; cerebral aneursym
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 13861