Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
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First Received Date ICMJE | July 20, 2012 | ||||||||
Last Updated Date | August 1, 2012 | ||||||||
Start Date ICMJE | August 2012 | ||||||||
Estimated Primary Completion Date | January 2017 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Occlusion Rate [ Time Frame: 12-18 Month Follow-up ] [ Designated as safety issue: No ] Occlusion rate: angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01655784 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Framing Eighteen Coils in Cerebral Aneurysms Trial | ||||||||
Official Title ICMJE | Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT | ||||||||
Brief Summary | This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter). Hypothesis: angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils. |
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Detailed Description | Primary Study Objective: Occlusion rate: angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization. Secondary Objectevies:
Study Design: FEAT will be a prospective, randomized trial comparing the utilization of 0.014-0.0155" coils versus smaller diameter coils in mid-sized aneurysm treatment. The 0.014-0.0155" bare platinum coils (Stryker, Natick, MA) are FDA-approved and in common use at institutions in this country and across the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to either the framing coil treatment or the non-framing coil treatment. Data on each patient will be collected at the time of enrollment and treatment, and at first and second follow-up visits. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Cerebral Aneurysm | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE | 660 | ||||||||
Estimated Completion Date | June 2017 | ||||||||
Estimated Primary Completion Date | January 2017 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 21 Years to 79 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655784 | ||||||||
Other Study ID Numbers ICMJE | 120439 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | JD Mocco, Vanderbilt University | ||||||||
Study Sponsor ICMJE | Vanderbilt University | ||||||||
Collaborators ICMJE | Stryker Neurovascular | ||||||||
Investigators ICMJE |
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Information Provided By | Vanderbilt University | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |