Framing Eighteen Coils in Cerebral Aneurysms Trial

Completed · Not applicable

Conditions studied: Cerebral Aneurysm

In brief

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.

Key facts

Study ID

NCT01655784

Run by

Vanderbilt University Medical Center

People needed

651

Starts

2012-12-04

Expected to finish

2024-02-19

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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