EffectiveNess and SAfety of Small ANeurysm COiling Trial
NANO
1 other identifier
observational
252
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 18, 2016
August 1, 2016
4.1 years
June 17, 2014
August 17, 2016
Conditions
Outcome Measures
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.
18 Months
Eligibility Criteria
Patients with cerebral aneurysms less than 4mm
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- Stryker Neurovascularcollaborator
Study Sites (19)
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Radiology Imaging Associates
Englewood, Colorado, 80112, United States
University of Florida
Gainesville, Florida, 32610, United States
Lyerly Neurosurgery, Affiliate of Baptist Health
Jacksonville, Florida, 32207, United States
Norton Neuroscience Institute
Louisville, Kentucky, 40241, United States
Maine Medical Center
Scarborough, Maine, 04074, United States
University of Massachusettes
Worcester, Massachusetts, 01655, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Riverside Research and Discovery- Riverside Health System
Newport News, Virginia, 23601, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, 23456, United States
Swedish Neurosciences Research
Seattle, Washington, 98122, United States
Aurora Research Institute
Milwaukee, Wisconsin, 53233, United States
CHUM - Hôpital Notre-Dame Hospital
Montreal, Quebec, QC H2L 4M1, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avery J Evans, MD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Radiology
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
August 18, 2016
Record last verified: 2016-08