Cerebral AneurysmFEATNCT01655784
Framing Eighteen Coils in Cerebral Aneurysms Trial
A study testing Coil Embolization with larger Diameter Coils and Coil Embolization with Standard Diameter Coils in people with Cerebral Aneurysm, run by Vanderbilt University Medical Center at 24 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Coil Embolization with larger Diameter Coils and Coil Embolization with Standard Diameter Coils
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 24 sitesUnited States
- Study dates
- 4 Dec 2012to 19 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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).
- Target aneurysm has had previous coil treatment or has been surgically clipped.
- Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.
- Inability to obtain informed consent.
- Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
University of Buffalo
Buffalo, New York, 14203
Medical Center of South Carolina
Charleston, South Carolina, 29425
Tennessee Interventional Associates - Erlanger
Chattanooga, Tennessee, 37403
Mayfield Clinic
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43210
University of Texas - Southwestern
Dallas, Texas, 75390
Radiology Imaging Associates
Englewood, Colorado, 80112
Colorado Neurological Institute
Englewood, Colorado, 80113
UCSF-Fresno, Community Regional Medical Center
Fresno, California, 93701
University of Florida
Gainesville, Florida, 32611
Prisma Health
Greenville, South Carolina, 29615
University of Mississippi
Jackson, Mississippi, 39216
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
University of Tennessee Medical Center - Knoxville
Knoxville, Tennessee, 37920
University of Kentucky
Lexington, Kentucky, 40536
Methodist University Hospital
Memphis, Tennessee, 38104
West Virginia University Hospital
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Massachusetts Medical School
North Worcester, Massachusetts, 01655
Virginia Commonwealth University
Richmond, Virginia, 23298
Stony Brook University
Stony Brook, New York, 11794
University of South Florida - Tampa General
Tampa, Florida, 33606
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
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.
Read the 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:
- Treatment related morbidity and mortality, as measured by the NIH stroke scale.
- Packing density as measured by volumetric filling of the aneurysm.
- Clinical outcome at 3-6 and 12-18 months post-coiling, as measured by the modified Rankin scale.
- 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.
- Conditions
- Cerebral Aneurysm
- Being tested
- Coil Embolization with larger Diameter Coils, Coil Embolization with Standard Diameter Coils
- Keywords
- aneurysm, intracranial aneurysm, cerebral aneurysm, intracranial embolization, aneurysm embolization, intracranial coil, eighteen coils, bare platinum coils, GDC Coil, Target Coil
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil Embolization with larger Diameter CoilsProcedure or surgery
Also called Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm Coils
Eighteen Coils placed in cerebral aneurysm
Coil Embolization with Standard Diameter CoilsProcedure or surgery
Also called Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm Coils
Cerebral aneurysms will be embolized with standard diameter coils.
| Study group | Role | What they receive |
|---|---|---|
| Eighteen Coils (0.014-0.0155 inch) | Active comparator | 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. Receives: Procedure: Coil Embolization with larger Diameter Coils |
| Standard Coils (0.014 inch) | Active comparator | 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. Receives: Procedure: Coil Embolization with Standard Diameter Coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion Rate
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.
Measured: 12-18 Month Follow-up
Secondary outcomes (6)
Morbidity
Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.
Measured: Entire Study Duration (from signed research consent until 12-18 month follow-up complete)
Packing Density
Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
Measured: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)
Clinical Outcome
Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.
Measured: 3-6 Month Follow-up and 12-18 Month Follow-up
Re-hemorrhage and Re-treatment Rates
Re-hemorrhage rates will be tracked and recorded during both follow-up time points.
Measured: 3-6 Month Follow-up and 12-18 Month Follow-up
Mortality
Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.
Measured: Entire Study Duration (from study procedure until 12-18 month follow-up)
Retreatment
Retreatment rates will be tracked and recorded during both follow-up time points.
Measured: 3-6 Month Follow-up and 12-18 Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study start4 Dec 2012
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular
- Responsible party
- Principal investigator, JD Mocco, Vanderbilt University Medical Center
- Investigators
- J D Mocco, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655784
- Sponsor's protocol ID
- 120439
- Acronym
- FEAT
- Status last verified
- Feb 2025
- First submitted
- 20 Jul 2012
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
- ClinicalTrials.gov ID
- NCT01655784
- Acronym / sponsor ID
- FEAT / 120439
- Conditions
- Cerebral Aneurysm
- Keywords
- aneurysm, intracranial aneurysm, cerebral aneurysm, intracranial embolization, aneurysm embolization, intracranial coil, eighteen coils, bare platinum coils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Neurovascular
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Treatment related morbidity and mortality, as measured by the NIH stroke scale.
- Packing density as measured by volumetric filling of the aneurysm.
- Clinical outcome at 3-6 and 12-18 months post-coiling, as measured by the modified Rankin scale.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eighteen Coils (0.014-0.0155 inch) | Active comparator | Procedure: Coil Embolization with larger Diameter CoilsSubjects 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. |
| Standard Coils (0.014 inch) | Active comparator | Procedure: Coil Embolization with Standard Diameter CoilsSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
- Target aneurysm has had previous coil treatment or has been surgically clipped.
- Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.
- Inability to obtain informed consent.
- Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coil Embolization with larger Diameter CoilsAlso: Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm CoilsEighteen Coils placed in cerebral aneurysm | Procedure or surgery | Eighteen Coils (0.014-0.0155 inch) |
| Coil Embolization with Standard Diameter CoilsAlso: Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm CoilsCerebral aneurysms will be embolized with standard diameter coils. | Procedure or surgery | Standard Coils (0.014 inch) |
Primary outcome
Occlusion Rate
Time frame: 12-18 Month Follow-up
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.
6 secondary outcomes
Morbidity
Time frame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete)
Packing Density
Time frame: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)
Clinical Outcome
Time frame: 3-6 Month Follow-up and 12-18 Month Follow-up
Re-hemorrhage and Re-treatment Rates
Time frame: 3-6 Month Follow-up and 12-18 Month Follow-up
Mortality
Time frame: Entire Study Duration (from study procedure until 12-18 month follow-up)
Retreatment
Time frame: 3-6 Month Follow-up and 12-18 Month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Vanderbilt University Medical Center-Department of Neurological SurgeryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J D Mocco, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil Embolization with larger Diameter Coils and Coil Embolization with Standard Diameter Coils in people with Cerebral Aneurysm, run by Vanderbilt University Medical Center at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion Rate (time frame: 12-18 Month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.