EffectiveNess and SAfety of Small ANeurysm COiling Trial

Status unconfirmed

Conditions studied: Aneurysm

In brief

To compare the safety and efficacy of treating small aneurysms with coils specially designed for small aneurysms to historically reported rates of safety and efficacy for the treatment of larger aneurysms.

Key facts

Study ID

NCT02167997

Run by

University of Virginia

People needed

252

Starts

2013-11-01

Expected to finish

2018-12-01

Last updated by the study team

2016-08-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
• Patients between (and including) 18 and 90 years of age.
• Patient HUNT AND HESS Grade 0-3.
• Where required, patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their surrogate, or from appropriate power of attorney.
• Aneurysm < 4mm in maximum diameter.
• Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.
• The aneurysm has not previously been treated (by coiling or clipping).
• A three-dimensional angiogram has been performed.
• Placement of at least one "Nano" coil, at, or at least close to the neck of the aneurysm.

You may not qualify if…

• Patient has more than one aneurysm requiring treatment in the current treatment session. If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).
• Patient has an H\&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
• Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.
• Less than 80% by length of Stryker endovascular coils are implanted.

Where it is running

• Santa Barbara Cottage Hospital — Santa Barbara, California, United States (enrolling)
• Radiology Imaging Associates — Englewood, Colorado, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Lyerly Neurosurgery, Affiliate of Baptist Health — Jacksonville, Florida, United States (enrolling)
• Norton Neuroscience Institute — Louisville, Kentucky, United States (enrolling)
• Maine Medical Center — Scarborough, Maine, United States (enrolling)
• University of Massachusettes — Worcester, Massachusetts, United States (enrolling)
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Riverside Research and Discovery- Riverside Health System — Newport News, Virginia, United States (enrolling)
• Sentara Neuroscience Institute — Virginia Beach, Virginia, United States (enrolling)
• Swedish Neurosciences Research — Seattle, Washington, United States (enrolling)
• Aurora Research Institute — Milwaukee, Wisconsin, United States (enrolling)
• CHUM - Hôpital Notre-Dame Hospital — Montreal, Quebec, Canada (enrolling)
• University of Saskatchewan — Saskatoon, Saskatchewan, Canada (enrolling)

Full record on ClinicalTrials.gov

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