Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01655784
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2012-07-20
Brief Title:
Framing Eighteen Coils in Cerebral Aneurysms Trial
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Framing Eighteen Coils in Cerebral Aneurysms Trial FEAT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEAT
Brief Summary:
This trial is being conducted in order to compare angiographic outcomes in patients receiving 0014-00155 platinum framing and filling coils larger diameter coils versus those treated solely with coils less than 0014 with a standard diameter
Hypothesis Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0014-00155 platinum coils during embolization compared to those receiving smaller-diameter coils
Hypothesis Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0014-00155 platinum coils during embolization compared to those receiving smaller-diameter coils
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 Objectives
1 Treatment related morbidity and mortality as measured by the NIH stroke scale
2 Packing density as measured by volumetric filling of the aneurysm
3 Clinical outcome at 3-6 and 12-18 months post-coiling as measured by the modified Rankin scale
4 Re-hemorrhage and re-treatment rates
Study Design FEAT will be a prospective randomized trial comparing the utilization of 0014-00155 coils versus smaller diameter coils in mid-sized aneurysm treatment The 0014-00155 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 11 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
Secondary Objectives
1 Treatment related morbidity and mortality as measured by the NIH stroke scale
2 Packing density as measured by volumetric filling of the aneurysm
3 Clinical outcome at 3-6 and 12-18 months post-coiling as measured by the modified Rankin scale
4 Re-hemorrhage and re-treatment rates
Study Design FEAT will be a prospective randomized trial comparing the utilization of 0014-00155 coils versus smaller diameter coils in mid-sized aneurysm treatment The 0014-00155 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None