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Framing Eighteen Coils in Cerebral Aneurysms Trial

Key facts

Who runs it
Vanderbilt University Medical Center
Where
Buffalo, Charleston, Chattanooga, Cincinnati, Columbus, Dallas, Englewood, Fresno, Gainesville, Greenville, Jackson, Knoxville, Lexington, Memphis, Morgantown, Nashville, New York, North Worcester, Richmond, Stony Brook, Tampa, and Winston-Salem, United StatesSee the 24 sites
Trial code
Status
Completed
People taking part
651 people enrolled
Started
4 Dec 2012
Ended
19 Feb 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Coil Embolization with larger Diameter Coils
  • Coil Embolization with Standard Diameter Coils
Record updated
6 February 2025

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon)
  • The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.015-0.0155" platinum coil
  • Patients are 18-80 years of age (inclusive)
  • Patient must be Hunt and Hess grade 0 to 3
  • 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
  • Aneurysm 6-14 mm in maximum diameter
  • 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
  • The patient has not been previously randomized into this trial or another related ongoing trial
  • The aneurysm has not been previously treated by coiling or clipping

Who cannot take part

  • Target aneurysm has had previous coil treatment or has been surgically clipped
  • Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years
  • Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
  • 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)
  • Inability to obtain informed consent

Where in United States

  • University of BuffaloBuffalo, United StatesNo longer taking part
  • Medical Center of South CarolinaCharleston, United StatesNo longer taking part
  • Tennessee Interventional Associates - ErlangerChattanooga, United StatesNo longer taking part
  • Mayfield ClinicCincinnati, United StatesNo longer taking part
  • Ohio State UniversityColumbus, United StatesNo longer taking part
  • University of Texas, SouthwesternDallas, United StatesNo longer taking part
  • Colorado Neurological InstituteEnglewood, United StatesNo longer taking part
  • Radiology Imaging AssociatesEnglewood, United StatesNo longer taking part
  • UCSF-Fresno, Community Regional Medical CenterFresno, United StatesNo longer taking part
  • University of FloridaGainesville, United StatesNo longer taking part
  • Prisma HealthGreenville, United StatesNo longer taking part
  • University of MississippiJackson, United StatesNo longer taking part
  • Fort Sanders Regional Medical CenterKnoxville, United StatesNo longer taking part
  • University of Tennessee Medical Center KnoxvilleKnoxville, United StatesNo longer taking part
  • University of KentuckyLexington, United StatesNo longer taking part
  • Methodist University HospitalMemphis, United StatesNo longer taking part
  • West Virginia University HospitalMorgantown, United StatesNo longer taking part
  • Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
  • Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
  • University of Massachusetts Medical SchoolNorth Worcester, United StatesNo longer taking part
  • Virginia Commonwealth UniversityRichmond, United StatesNo longer taking part
  • Stony Brook UniversityStony Brook, United StatesNo longer taking part
  • University of South Florida - Tampa GeneralTampa, United StatesNo longer taking part
  • Wake Forest Baptist HealthWinston-Salem, United StatesNo longer taking part

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Eighteen Coils (0.014-0.0155 inch)Existing treatment, for comparison

    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.

    Treatment: Coil Embolization with larger Diameter Coils

  • Standard Coils (0.014 inch)Existing treatment, for comparison

    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 depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical 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.

    Treatment: Coil Embolization with Standard Diameter Coils

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
Record updated
6 February 2025