Trials / Unknown
UnknownNCT02167997
EffectiveNess and SAfety of Small ANeurysm COiling Trial
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 252 (estimated)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2017-12-01
- Completion
- 2018-12-01
- First posted
- 2014-06-19
- Last updated
- 2016-08-18
Locations
19 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02167997. Inclusion in this directory is not an endorsement.