Framing Eighteen Coils in Cerebral Aneurysms Trial

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Brief Title

Framing Eighteen Coils in Cerebral Aneurysms Trial

Official Title

Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Brief Summary

      This trial is being conducted in order to compare angiographic outcomes in patients receiving
      0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated
      solely with coils less than 0.014" (with a standard diameter).

      Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients
      receiving 0.014-0.0155" platinum coils during embolization compared to those receiving
      smaller-diameter coils.
    

Detailed Description

      Primary Study Objective: 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 embolization.

      Secondary Objectives:

        1. Treatment related morbidity and mortality, as measured by the NIH stroke scale.

        2. Packing density as measured by volumetric filling of the aneurysm.

        3. Clinical outcome at 3-6 and 12-18 months post-coiling, as measured by the modified
           Rankin scale.

        4. Re-hemorrhage and re-treatment rates.

      Study Design: FEAT will be a prospective, randomized trial comparing the utilization of
      0.014-0.0155" coils versus smaller diameter coils in mid-sized aneurysm treatment. The
      0.014-0.0155" bare platinum coils (Stryker, Natick, MA) are FDA-approved and in common use at
      institutions in this country and across the world. Patients will be enrolled who meet the
      inclusion criteria and consent to participate. Patients will be randomly assigned by a
      central web-based system in a 1:1 manner to either the framing coil treatment or the
      non-framing coil treatment. Data on each patient will be collected at the time of enrollment
      and treatment, and at first and second follow-up visits.
    


Study Type

Interventional


Primary Outcome

Occlusion Rate

Secondary Outcome

 Morbidity

Condition

Cerebral Aneurysm

Intervention

Coil Embolization with larger Diameter Coils

Study Arms / Comparison Groups

 Eighteen Coils (0.014-0.0155 inch)
Description:  Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.

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

Procedure

Estimated Enrollment

660

Start Date

August 2012

Completion Date

January 2021

Primary Completion Date

January 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for
             endovascular treatment as determined by the neurovascular treating team
             (neurointerventionist and/or neurosurgeon).

          2. The neurointerventionist feels that the aneurysm can be safely treated with either
             using, or not using, a 0.015-0.0155" platinum coil.

          3. Patients are 18-80 years of age (inclusive).

          4. Patient must be Hunt and Hess grade 0 to 3.

          5. Patient has given fully informed consent to endovascular coiling procedure. If the
             patient cannot consent for themselves, appropriate written consent has been sought
             from their next of kin or appropriate power of attorney.

          6. Aneurysm 6-14 mm in maximum diameter.

          7. Patient is willing and able to return for clinical evaluation and follow-up imaging
             evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular
             treatment.

          8. The patient has not been previously randomized into this trial or another related
             ongoing trial.

          9. The aneurysm has not been previously treated by coiling or clipping.

        Exclusion Criteria:

          1. Patient has more than one aneurysm requiring treatment in the current treatment
             session, and only one of those to be treated aneurysms fits the FEAT inclusion
             criteria (ie - if either (1) a patient has multiple aneurysms, but only one will be
             treated at enrollment; or (2) if two or more aneurysms are treated during the current
             treatment session and BOTH are able to be enrolled, then they remain eligible for the
             trial). Non-treated additional aneurysms may be treated at a later date with any coil
             type that the operator chooses).

          2. Target aneurysm has had previous coil treatment or has been surgically clipped.

          3. Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.

          4. Inability to obtain informed consent.

          5. Medical or surgical co-morbidity such that the patient's life expectancy is less than
             2 years.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

J D Mocco, MD, MS, 6158758531, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01655784

Organization ID

120439


Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University Medical Center

Collaborators

 Stryker Neurovascular

Study Sponsor

J D Mocco, MD, MS, Principal Investigator, Icahn School of Medicine at Mount Sinai


Verification Date

March 2020