EffectiveNess and SAfety of Small ANeurysm COiling Trial (NANO)

August 17, 2016 updated by: Avery Evans, MD, University of Virginia
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, QC H2L 4M1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Santa Barbara Cottage Hospital
        • Contact:
        • Principal Investigator:
          • Alois Zauner, MD
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Recruiting
        • Radiology Imaging Associates
        • Contact:
        • Principal Investigator:
          • Richard Bellon, MD
    • Florida
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Lyerly Neurosurgery, Affiliate of Baptist Health
        • Contact:
        • Principal Investigator:
          • Eric Sauvageau, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40241
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Sanborn, MD
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Josser Delgado, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel Walzman, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Patrick Youssef, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Steven Hoover, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Avery J Evans, MD
      • Newport News, Virginia, United States, 23601
        • Recruiting
        • Riverside Research and Discovery- Riverside Health System
        • Contact:
        • Principal Investigator:
          • J. Frank Sanderson, MD
      • Virginia Beach, Virginia, United States, 23456
        • Recruiting
        • Sentara Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • John Agola, MD
    • Washington
      • Seattle, Washington, United States, 98122
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Research Institute
        • Contact:
        • Principal Investigator:
          • Akram Shhadeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cerebral aneurysms less than 4mm

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Stryker Neurovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (ESTIMATE)

June 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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