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Summary

for people ages 18–80 (full criteria)
at Fresno, California and other locations
study started
estimated completion:

Description

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.

Official Title

Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Details

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.

Keywords

Cerebral Aneurysm aneurysm intracranial aneurysm intracranial embolization aneurysm embolization intracranial coil eighteen coils bare platinum coils GDC Coil Target Coil

Eligibility

You can join if…

Open to people ages 18–80

  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.

You CAN'T join if...

  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.

Locations

  • UCSF-Fresno, Community Regional Medical Center accepting new patients
    Fresno, California, 93701, United States
  • Colorado Neurological Institute completed
    Englewood, Colorado, 80113, United States
  • Radiology Imaging Associates accepting new patients
    Englewood, Colorado, 80112, United States
  • University of Texas - Southwestern accepting new patients
    Dallas, Texas, 75390, United States
  • University of Tennessee - Memphis - Methodist accepting new patients
    Memphis, Tennessee, 38120, United States
  • University of Mississippi accepting new patients
    Jackson, Mississippi, 39216, United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville, Tennessee, 37212, United States
  • Mayfield Clinic accepting new patients
    Cincinnati, Ohio, 45219, United States
  • Tennessee Interventional Associates - Erlanger accepting new patients
    Chattanooga, Tennessee, 37403, United States
  • University of Kentucky accepting new patients
    Lexington, Kentucky, 40536, United States
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, 48109, United States
  • Fort Sanders Regional Medical Center accepting new patients
    Knoxville, Tennessee, 37916, United States
  • University of Tennessee Medical Center - Knoxville accepting new patients
    Knoxville, Tennessee, 37920, United States
  • Ohio State University accepting new patients
    Columbus, Ohio, 43210, United States
  • West Virginia University Hospital accepting new patients
    Morgantown, West Virginia, 26506, United States
  • Wake Forest Baptist Health accepting new patients
    Winston Salem, North Carolina, 27157, United States
  • University of Buffalo accepting new patients
    Buffalo, New York, 14203, United States
  • University of Florida accepting new patients
    Gainesville, Florida, 32611, United States
  • Lyerly Neurosurgery - Baptist Jacksonville accepting new patients
    Jacksonville, Florida, 32207, United States
  • University of South Florida - Tampa General accepting new patients
    Tampa, Florida, 33606, United States
  • Medical Center of South Carolina accepting new patients
    Charleston, South Carolina, 29425, United States
  • Virginia Commonwealth University accepting new patients
    Richmond, Virginia, 23298, United States
  • Icahn School of Medicine at Mount Sinai accepting new patients
    New York, New York, 10029, United States
  • Stony Brook University accepting new patients
    Stony Brook, New York, 11794, United States
  • University of Massachusetts Medical School accepting new patients
    North Worcester, Massachusetts, 01655, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt University
Links
Vanderbilt University Medical Center-Department of Neurological Surgery
ID
NCT01655784
Phase
Phase 3
Lead Scientist
Robert Ryan
Study Type
Interventional
Last Updated
February 27, 2017
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