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Status unknownNCT02167997NANOUpdated Aug 18, 2016

EffectiveNess and SAfety of Small ANeurysm COiling Trial

An observational study in Aneurysm, sponsored by University of Virginia. Status unknown at 19 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-18.

Sponsored by University of Virginia · Observational

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
252
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Aneurysm

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03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 252 is above the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cerebral aneurysms less than 4mm

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
252 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Procedural failure

    Defined as the composite of technical failure (inability to coil the aneurysm), and complication leading to permanent neurologic injury or death. The second primary outcome relates to the long term effectiveness of the procedure, and is defined as freedom from angiographic recurrence within a period of 12-18 months after the index procedure.

    Time frame: 18 Months

07

Study locations

19 of 19 sites recruiting
  • Santa Barbara Cottage Hospital
    Santa Barbara, California 93105, United States
    • Sharon Granoff · Contact · research@sbch.org
    • Alois Zauner, MD · Principal investigator
    Recruiting
  • Radiology Imaging Associates
    Englewood, Colorado 80112, United States
    Recruiting
  • University of Florida
    Gainesville, Florida 32610, United States
    Recruiting
  • Lyerly Neurosurgery, Affiliate of Baptist Health
    Jacksonville, Florida 32207, United States
    Recruiting
  • Norton Neuroscience Institute
    Louisville, Kentucky 40241, United States
    Recruiting
  • Maine Medical Center
    Scarborough, Maine 04074, United States
    • Deborah Cushing · Contact · CUSHID@mmc.org
    • Matthew Sanborn, MD · Principal investigator
    Recruiting
  • University of Massachusettes
    Worcester, Massachusetts 01655, United States
    Recruiting
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Recruiting
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
    Recruiting
  • The University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • University of Virginia
    Charlottesville, Virginia 22908, United States
    • Claire McKinley · Contact · cw9ne@virginia.edu
    • Avery J Evans, MD · Principal investigator
    Recruiting
  • Riverside Research and Discovery- Riverside Health System
    Newport News, Virginia 23601, United States
    Recruiting
  • Sentara Neuroscience Institute
    Virginia Beach, Virginia 23456, United States
    Recruiting
  • Swedish Neurosciences Research
    Seattle, Washington 98122, United States
    Recruiting
  • Aurora Research Institute
    Milwaukee, Wisconsin 53233, United States
    Recruiting
  • CHUM - Hôpital Notre-Dame Hospital
    Montreal, Quebec QC H2L 4M1, Canada
    Recruiting
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7N 0W8, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02167997
Lead sponsor
University of Virginia
Collaborators
Stryker Neurovascular
Responsible party
Avery Evans, MD (Professor, Department of Radiology, University of Virginia) — Principal investigator
First posted
Jun 19, 2014
Start date
Nov 2013
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 18, 2016

Study contacts

Claire L McKinley, CCRP
Contact
cw9ne@virginia.edu
434-924-9271
Avery J Evans, MD
principal investigator · University of Virginia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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