Aneurysm
Conditions
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).
Interventions
None listed
Sponsors
Stryker Neurovascular
University of Virginia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural failure | 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. |
Countries
Canada, United States
Contacts
Primary ContactClaire L McKinley, CCRP
Outcome results
None listed