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EffectiveNess and SAfety of Small ANeurysm COiling Trial (NANO)

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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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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