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
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Condition or disease |
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Aneurysm |
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 |

- 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.

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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 |
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.

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

Principal Investigator: | Avery J Evans, MD | University of Virginia |
Additional Information:
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:
Aneurysm Vascular Diseases Cardiovascular Diseases |