Clinical trial NCT01655784: Framing Eighteen Coils in Cerebral Aneurysms Trial
Official title: Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: aneurysm
intracranial aneurysm
cerebral aneurysm
intracranial embolization
aneurysm embolization
intracranial coil
eighteen coils
bare platinum coils
GDC Coil
Target Coil
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2012-08-02
Enrollment: 651
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Occlusion Rate
timeFrame: 12-18 Month Follow-up
Secondary outcomes:
measure: Morbidity
timeFrame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete)
measure: Packing Density
timeFrame: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)
measure: Clinical Outcome
timeFrame: 3-6 Month Follow-up and 12-18 Month Follow-up
measure: Re-hemorrhage and Re-treatment Rates
timeFrame: 3-6 Month Follow-up and 12-18 Month Follow-up
measure: Mortality
timeFrame: Entire Study Duration (from study procedure until 12-18 month follow-up)
measure: Retreatment
timeFrame: 3-6 Month Follow-up and 12-18 Month Follow-up
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF-Fresno, Community Regional Medical Center
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida - Tampa General
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: North Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: Mayfield Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical Center of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Interventional Associates - Erlanger
state: Tennessee
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center - Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas - Southwestern
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: J D Mocco, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: