Framing Eighteen Coils in Cerebral Aneurysms Trial
- Conditions
- Cerebral Aneurysm
- Registration Number
- NCT01655784
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 651
Inclusion Criteria:<br><br> 1. Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for<br> endovascular treatment as determined by the neurovascular treating team<br> (neurointerventionist and/or neurosurgeon).<br><br> 2. The neurointerventionist feels that the aneurysm can be safely treated with either<br> using, or not using, a 0.015-0.0155 platinum coil.<br><br> 3. Patients are 18-80 years of age (inclusive).<br><br> 4. Patient must be Hunt and Hess grade 0 to 3.<br><br> 5. Patient has given fully informed consent to endovascular coiling procedure. If the<br> patient cannot consent for themselves, appropriate written consent has been sought<br> from their next of kin or appropriate power of attorney.<br><br> 6. Aneurysm 6-14 mm in maximum diameter.<br><br> 7. Patient is willing and able to return for clinical evaluation and follow-up imaging<br> evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular<br> treatment.<br><br> 8. The patient has not been previously randomized into this trial or another related<br> ongoing trial.<br><br> 9. The aneurysm has not been previously treated by coiling or clipping.<br><br>Exclusion Criteria:<br><br> 1. Patient has more than one aneurysm requiring treatment in the current treatment<br> session, and only one of those to be treated aneurysms fits the FEAT inclusion<br> criteria (ie - if either (1) a patient has multiple aneurysms, but only one will be<br> treated at enrollment; or (2) if two or more aneurysms are treated during the<br> current treatment session and BOTH are able to be enrolled, then they remain<br> eligible for the trial). Non-treated additional aneurysms may be treated at a later<br> date with any coil type that the operator chooses).<br><br> 2. Target aneurysm has had previous coil treatment or has been surgically clipped.<br><br> 3. Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.<br><br> 4. Inability to obtain informed consent.<br><br> 5. Medical or surgical co-morbidity such that the patient's life expectancy is less<br> than 2 years.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occlusion Rate
- Secondary Outcome Measures
Name Time Method Morbidity;Packing Density;Clinical Outcome;Re-hemorrhage and Re-treatment Rates;Mortality;Retreatment