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EffectiveNess and SAfety of Small ANeurysm COiling Trial (NANO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02167997
Recruitment Status : Unknown
Verified August 2016 by Avery Evans, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : June 19, 2014
Last Update Posted : August 18, 2016
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Avery Evans, MD, University of Virginia

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.

Condition or disease
Aneurysm

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: EffectiveNess and SAfety of Small ANeurysm COiling Trial
Study Start Date : November 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cerebral aneurysms less than 4mm
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167997


Contacts
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Contact: Claire L McKinley, CCRP 434-924-9271 cw9ne@virginia.edu

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Locations
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United States, California
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Sharon Granoff       research@sbch.org   
Principal Investigator: Alois Zauner, MD         
United States, Colorado
Radiology Imaging Associates Recruiting
Englewood, Colorado, United States, 80112
Contact: Michelle Lexin       Michelle.Lexin@riaco.com   
Principal Investigator: Richard Bellon, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Jessica Smith       Jessica.Smith@neurosurgery.ufl.edu   
Principal Investigator: Adam Polifka, MD         
Lyerly Neurosurgery, Affiliate of Baptist Health Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Ebreo       Nancy.Ebreo@bmcjax.com   
Principal Investigator: Eric Sauvageau, MD         
United States, Kentucky
Norton Neuroscience Institute Recruiting
Louisville, Kentucky, United States, 40241
Contact: Sherry Roberts       Sherry.Roberts@nortonhealthcare.org   
Principal Investigator: Shervin Dashti, MD         
United States, Maine
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
Contact: Deborah Cushing       CUSHID@mmc.org   
Principal Investigator: Matthew Sanborn, MD         
United States, Massachusetts
University of Massachusettes Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Mary Howk       mary.howk@umassmed.edu   
Principal Investigator: Ajit Puri, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jennifer Fease       jennifer.fease@allina.com   
Principal Investigator: Josser Delgado, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Jana Tancredi       JTancredi@HackensackUMC.org   
Principal Investigator: Daniel Walzman, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kathryn Jelinek       Kathryn.Jelinek@osumc.edu   
Principal Investigator: Patrick Youssef, MD         
United States, Oklahoma
The University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Brittany Smith       Brittany-Smith@ouhsc.edu   
Principal Investigator: Steven Hoover, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Alberto Montano       Alberto.Montano@jefferson.edu   
Principal Investigator: Stavropoula Tjoumakaris, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Claire McKinley       cw9ne@virginia.edu   
Principal Investigator: Avery J Evans, MD         
Riverside Research and Discovery- Riverside Health System Recruiting
Newport News, Virginia, United States, 23601
Contact: Cheryl White       Cheryl.White@rivhs.com   
Principal Investigator: J. Frank Sanderson, MD         
Sentara Neuroscience Institute Recruiting
Virginia Beach, Virginia, United States, 23456
Contact: Jennifer Kennedy       JMKENNE2@sentara.com   
Principal Investigator: John Agola, MD         
United States, Washington
Swedish Neurosciences Research Recruiting
Seattle, Washington, United States, 98122
Contact: Carol Kemp       Carol.Kemp@swedish.org   
Contact: Caryl Tongco       Caryl.Tongco@swedish.org   
Principal Investigator: Stephen Monteith, MD         
United States, Wisconsin
Aurora Research Institute Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Jennifer Mathieu       Jennifer.Mathieu@aurora.org   
Principal Investigator: Akram Shhadeh, MD         
Canada, Quebec
CHUM - Hôpital Notre-Dame Hospital Recruiting
Montreal, Quebec, Canada, QC H2L 4M1
Contact: Suzanne Nolet       Suzanne.Nolet@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Lilian Urroz       lilian.urroz@usask.ca   
Principal Investigator: Michael Kelly, MD         
Sponsors and Collaborators
University of Virginia
Stryker Neurovascular
Investigators
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Principal Investigator: Avery J Evans, MD University of Virginia

Additional Information:

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Responsible Party: Avery Evans, MD, Professor, Department of Radiology, University of Virginia
ClinicalTrials.gov Identifier: NCT02167997     History of Changes
Other Study ID Numbers: 17155
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases