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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

Tracking Information
First Submitted Date June 17, 2014
First Posted Date June 19, 2014
Last Update Posted Date August 18, 2016
Study Start Date November 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02167997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title EffectiveNess and SAfety of Small ANeurysm COiling Trial
Official Title EffectiveNess and SAfety of Small ANeurysm COiling Trial
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with cerebral aneurysms less than 4mm
Condition Aneurysm
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 17, 2014)
252
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02167997
Other Study ID Numbers 17155
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Avery Evans, MD, University of Virginia
Study Sponsor University of Virginia
Collaborators Stryker Neurovascular
Investigators
Principal Investigator: Avery J Evans, MD University of Virginia
PRS Account University of Virginia
Verification Date August 2016