Clinical trial NCT02167997: EffectiveNess and SAfety of Small ANeurysm COiling Trial
Official title: EffectiveNess and SAfety of Small ANeurysm COiling Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysm
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2014-06-19
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebral aneurysms less than 4mm

Brief summary: 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.

Detailed description: This is a prospective cohort study whereby patients who undergo endovascular treatment with coils for intracranial aneurysms will be studied for initial procedural and 12-18 month post-treatment outcome. The procedural failure rate (defined above) of treating small aneurysms with specially designed coils will be compared to pre-specified historical occurrences. This evaluation will occur within the framework of "non-inferiority" (i.e. comparable success to coiling of large aneurysms).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Procedural failure
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery, Affiliate of Baptist Health
state: Florida
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Worcester
country: United States
facility: University of Massachusettes
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Newport News
country: United States
facility: Riverside Research and Discovery- Riverside Health System
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Neuroscience Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Neurosciences Research
state: Washington
city: Milwaukee
country: United States
facility: Aurora Research Institute
state: Wisconsin
city: Montreal
country: Canada
facility: CHUM - Hôpital Notre-Dame Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Virginia
name: Avery J Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: