HydroCoil Cerebral Aneurysm Treatment Trial

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Brief Title

HydroCoil Cerebral Aneurysm Treatment Trial

Official Title

HydroCoil Cerebral Aneurysm Treatment Trial

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Occlusion rate

Secondary Outcome

 Treatment related morbidity and mortality

Condition

Intracerebral Aneursym

Intervention

MicroVention Hydrogel coil

Study Arms / Comparison Groups

 MicroVention Hydrogel Coils
Description:  FDA approved and in common use for cerebral aneurysm treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

215

Start Date

December 2008

Completion Date

June 2015

Primary Completion Date

April 2013

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.

             -
      

Gender

All

Ages

21 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Avery J Evans, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01195129

Organization ID

13861


Responsible Party

Sponsor

Study Sponsor

University of Virginia

Collaborators

 Microvention-Terumo, Inc.

Study Sponsor

Avery J Evans, MD, Principal Investigator, University of Virginia


Verification Date

December 2014