Trial record 1 of 184 for:    Cerebral Aneurysm
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Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

This study is currently recruiting participants.
Verified July 2013 by Vanderbilt University
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
JD Mocco, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01655784
First received: July 20, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Cerebral Aneurysm
Procedure: Coil Embolization with larger Diameter Coils
Procedure: Coil Embolization with Standard Diameter Coils
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Occlusion Rate [ Time Frame: 12-18 Month Follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Morbidity [ Time Frame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete) ] [ Designated as safety issue: No ]
    Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.

  • Packing Density [ Time Frame: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed) ] [ Designated as safety issue: No ]
    Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.

  • Clinical Outcome [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ] [ Designated as safety issue: No ]
    Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.

  • Re-hemorrhage and Re-treatment Rates [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ] [ Designated as safety issue: No ]
    Re-hemorrhage rates will be tracked and recorded during both follow-up time points.

  • Cost [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ] [ Designated as safety issue: No ]
    Costs of each arm will be compared.

  • Mortality [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ] [ Designated as safety issue: No ]
    Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.

  • Retreatment [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ] [ Designated as safety issue: No ]
    Retreatment rates will be tracked and recorded during both follow-up time points.


Estimated Enrollment: 660
Study Start Date: August 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eighteen Coils (0.014-0.0155 inch)
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: 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.
Procedure: Coil Embolization with larger Diameter Coils
Eighteen Coils placed in cerebral aneurysm
Other Names:
  • Eighteen Coils
  • Cerebral Aneurysm Embolization
  • Aneurysm Coils
Active Comparator: Standard Coils (0.014 inch)
Subjects who randomize to this arm will receive the standard 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: Target 360 Standard, Target 360 Soft, Target 360 Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.
Procedure: Coil Embolization with Standard Diameter Coils
Cerebral aneurysms will be embolized with standard diameter coils.
Other Names:
  • Eighteen Coils
  • Cerebral Aneurysm Embolization
  • Aneurysm 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.
  5. Cost of therapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 at least 18 years old and less than 80 years of age.
  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 7-14 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655784

Contacts
Contact: Bree L Burks, RN, BSN 6158757606 Bree.Burks@vanderbilt.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Nicolle Davis    352-273-7774    nicolle.wilson@neurosurgery.ufl.edu   
Contact: Renee Boyette    352-273-7935    renee.boyette@neurosurgery.ufl.edu   
Principal Investigator: Spiros Blackburn, MD         
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Dawn Madigan    631-444-8121    dawn.madigan@sbumed.org   
Principal Investigator: David Fiorella, MD, PhD         
United States, Ohio
Mayfield Clinic Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Becky Reinert    513-558-0496    gibsonrk@ucmail.uc.edu   
Contact: Carolyn Koenig, RN, MS, CNS    513-558-3518    koenigch@ucmail.uc.edu   
Principal Investigator: Andrew Ringer, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Kathryn Jelinek    614-688-6853    kathryn.jelinek@osumc.edu   
Principal Investigator: Eric Sauvageau, MD         
Sub-Investigator: Ciaran Powers, MD, PhD         
United States, South Carolina
Medical Center of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Adrian Parker    843-792-3164    parkerad@musc.edu   
Principal Investigator: Raymond Turner, MD, FAANS         
Sub-Investigator: Aquilla Turk, DO         
United States, Tennessee
University of Tennessee - Memphis - Methodist Not yet recruiting
Memphis, Tennessee, United States, 38120
Contact: Hani Rashed, MD    901-516-8133    hani.rashed@mlh.org   
Principal Investigator: Adam Arthur, MD, MPH         
Sub-Investigator: Daniel Hoit, MD, MPH         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: J D Mocco, MD, MS    615-875-7606    J.Mocco@vanderbilt.edu   
Contact: Stephanie A Smith, MA, CCRP    615-936-0815    stephanie.anne.smith@vanderbilt.edu   
Principal Investigator: J D Mocco, MD, MS         
United States, Texas
University of Texas - Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Kim Dutton-Johnson    214-648-7815    kim.dutton@utsouthwestern.edu   
Principal Investigator: Babu Welch, MD         
Sub-Investigator: G. Lee Pride, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Charlotte Gilman, RN    804-828-9882    cgilman@mcvh-vcu.edu   
Principal Investigator: John Reavey-Cantwell, MD, MS         
Sub-Investigator: Scott Simon, MD         
United States, West Virginia
West Virginia University Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jennifer Domico, RN, CCRP    304-598-6930    domicoj@wvuhealthcare.com   
Principal Investigator: Ansaar Rai, MD         
Sub-Investigator: Jeffrey Carpenter, MD         
Sponsors and Collaborators
Vanderbilt University
Stryker Neurovascular
Investigators
Principal Investigator: J D Mocco, MD, MS Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: JD Mocco, J Mocco, MD, MS Associate Professor Department of Neurological Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01655784     History of Changes
Other Study ID Numbers: 120439
Study First Received: July 20, 2012
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
aneurysm
intracranial aneurysm
cerebral aneurysm
intracranial embolization
aneurysm embolization
intracranial coil
Eighteen Coils
Bare platinum coils
GDC Coil

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014