AneurysmNANONCT02167997
EffectiveNess and SAfety of Small ANeurysm COiling Trial
An observational study of Aneurysm, run by University of Virginia at 19 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aneurysm
- How many people
- 252 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Nov 2013to Dec 2018
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cerebral aneurysms less than 4mm
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States17 sites, 17 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Claire McKinley, cw9ne@virginia.edu
Avery J Evans, MD
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Kathryn Jelinek, Kathryn.Jelinek@osumc.edu
Patrick Youssef, MD
- Recruiting
Radiology Imaging Associates
Englewood, Colorado, 80112
Michelle Lexin, Michelle.Lexin@riaco.com
Richard Bellon, MD
- Recruiting
University of Florida
Gainesville, Florida, 32610
Jessica Smith, Jessica.Smith@neurosurgery.ufl.edu
Adam Polifka, MD
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Jana Tancredi, JTancredi@HackensackUMC.org
Daniel Walzman, MD
- Recruiting
Lyerly Neurosurgery, Affiliate of Baptist Health
Jacksonville, Florida, 32207
Nancy Ebreo, Nancy.Ebreo@bmcjax.com
Eric Sauvageau, MD
- Recruiting
Norton Neuroscience Institute
Louisville, Kentucky, 40241
Sherry Roberts, Sherry.Roberts@nortonhealthcare.org
Shervin Dashti, MD
- Recruiting
Aurora Research Institute
Milwaukee, Wisconsin, 53233
Jennifer Mathieu, Jennifer.Mathieu@aurora.org
Akram Shhadeh, MD
- Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Jennifer Fease, jennifer.fease@allina.com
Josser Delgado, MD
- Recruiting
Riverside Research and Discovery- Riverside Health System
Newport News, Virginia, 23601
Cheryl White, Cheryl.White@rivhs.com
J. Frank Sanderson, MD
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Brittany Smith, Brittany-Smith@ouhsc.edu
Steven Hoover, MD
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Alberto Montano, Alberto.Montano@jefferson.edu
Stavropoula Tjoumakaris, MD
- Recruiting
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Sharon Granoff, research@sbch.org
Alois Zauner, MD
- Recruiting
Maine Medical Center
Scarborough, Maine, 04074
Deborah Cushing, CUSHID@mmc.org
Matthew Sanborn, MD
- Recruiting
Swedish Neurosciences Research
Seattle, Washington, 98122
Carol Kemp, Carol.Kemp@swedish.org
Caryl Tongco, Caryl.Tongco@swedish.org
- Recruiting
Sentara Neuroscience Institute
Virginia Beach, Virginia, 23456
Jennifer Kennedy, JMKENNE2@sentara.com
John Agola, MD
- Recruiting
University of Massachusettes
Worcester, Massachusetts, 01655
Mary Howk, mary.howk@umassmed.edu
Ajit Puri, MD
Canada2 sites, 2 recruiting
- Recruiting
CHUM - Hôpital Notre-Dame Hospital
Montreal, Quebec, QC H2L 4M1
Suzanne Nolet, Suzanne.Nolet@crchum.qc.ca
Jean Raymond, MD
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Lilian Urroz, lilian.urroz@usask.ca
Michael Kelly, MD
About this study
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).
- Conditions
- Aneurysm
- Medical subject headings
- Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular
- Responsible party
- Principal investigator, Avery Evans, MD, University of Virginia
- Investigators
- Avery J Evans, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167997
- Sponsor's protocol ID
- 17155
- Acronym
- NANO
- Status last verified
- Aug 2016
- First submitted
- 17 Jun 2014
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EffectiveNess and SAfety of Small ANeurysm COiling Trial
- ClinicalTrials.gov ID
- NCT02167997
- Acronym / sponsor ID
- NANO / 17155
- Conditions
- Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Stryker Neurovascular
- Study start
- Nov 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cerebral aneurysms less than 4mm
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural failure
Time frame: 18 Months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avery J Evans, MD principal investigator
University of Virginia
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, run by University of Virginia at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire L McKinley, CCRP (434-924-9271, cw9ne@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural failure (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.