An observational study in Aneurysm, sponsored by University of Virginia. Status unknown at 19 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-18.
Sponsored by University of Virginia · Observational
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.
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).
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's planned enrollment of 252 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with cerebral aneurysms less than 4mm
Exclusion Criteria:
Procedural failure
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.
Time frame: 18 Months
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of Virginia