Framing Eighteen Coils in Cerebral Aneurysms Trial

Cerebral Aneurysm Clinical Trial

— FEAT  

Official title:

Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01655784
• Other study ID #: 120439
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2012
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 651
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Procedure:
• Coil Embolization with larger Diameter Coils
Eighteen Coils placed in cerebral aneurysm
• Coil Embolization with Standard Diameter Coils
Cerebral aneurysms will be embolized with standard diameter coils.

Locations

Country	Name	City	State
United States	University of Buffalo	Buffalo	New York
United States	Medical Center of South Carolina	Charleston	South Carolina
United States	Tennessee Interventional Associates - Erlanger	Chattanooga	Tennessee
United States	Mayfield Clinic	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas - Southwestern	Dallas	Texas
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Radiology Imaging Associates	Englewood	Colorado
United States	UCSF-Fresno, Community Regional Medical Center	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Prisma Health	Greenville	South Carolina
United States	University of Mississippi	Jackson	Mississippi
United States	Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	University of Tennessee Medical Center - Knoxville	Knoxville	Tennessee
United States	University of Kentucky	Lexington	Kentucky
United States	Methodist University Hospital	Memphis	Tennessee
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Massachusetts Medical School	North Worcester	Massachusetts
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Stony Brook University	Stony Brook	New York
United States	University of South Florida - Tampa General	Tampa	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12-18 Month Follow-up
Secondary	Morbidity	Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.	Entire Study Duration (from signed research consent until 12-18 month follow-up complete)
Secondary	Packing Density	Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.	Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)
Secondary	Clinical Outcome	Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.	3-6 Month Follow-up and 12-18 Month Follow-up
Secondary	Re-hemorrhage and Re-treatment Rates	Re-hemorrhage rates will be tracked and recorded during both follow-up time points.	3-6 Month Follow-up and 12-18 Month Follow-up
Secondary	Mortality	Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.	Entire Study Duration (from study procedure until 12-18 month follow-up)
Secondary	Retreatment	Retreatment rates will be tracked and recorded during both follow-up time points.	3-6 Month Follow-up and 12-18 Month Follow-up

External Links

•   Vanderbilt University Medical Center-Department of Neurological Surgery