Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499508
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2020-07-28
Brief Title:
Appraising the Embolization of Aneurysms Using Balt Optima Coil System APPLY Study
Sponsor:
Vascular Neurology of Southern California Inc
Organization:
Vascular Neurology of Southern California Inc
Study Overview
Official Title:
APPLY Study A Prospective Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima Coil System
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
APPLY
Brief Summary:
In recent years many developments have been made to the tools and techniques used to treat IAs via endovascular intervention Specifically to the detachable coils themselves In March 2018 the US Food and Drug administration granted Balt USA 510k clearance for the Optima Coil System Earlier this year the list of devices included within the system has expanded to include OptiMAX Complex Super Soft and Complex Soft coils It consists of coils that come in Standard Soft and Super Soft profiles and allows for instant detachment from the pusher The APPLY study is a prospective single-center investigator-initiated study meant to assess the use of the Balt Optima Coil System The site is looking to enroll approximately 30 subjects over the course of two years The Optima Coil System is commercially available in the United States as such this study is looking for real-world data
Detailed Description:
Intracranial aneurysms both ruptured and unruptured collectively affect a significant portion of the general population Cases of unruptured intracranial aneurysms UIA are estimated to affect roughly 3 of the general population and aneurysmal subarachnoid hemorrhage aSAH has an incidence of 8 to 9 people per 100000 There are two well-established treatment options for patients diagnosed with intracranial aneurysms IA surgical clipping and endovascular coiling Neurosurgical intervention requires a craniotomy followed by the clipping of the aneurysm Endovascular repair is minimally invasive as access to the afflicted vessel is gained through the femoral artery with the assistance of imaging guidance During embolization the aneurysm is occluded using coils of varying length diameter and softness By filling the dome of the aneurysm physicians aim to prevent further blood flow into the bulge which will prevent the aneurysm from rupturing In addition to coiling a stent may be placed to function as a blood flow diverting device
The first-ever recorded use of coils in the treatment of intracranial aneurysms by way of endovascular intervention was in 1988 In 1989 detachable coils were designed by Guido Guglielmi an endovascular neurosurgeon who pioneered the concept of coil embolization Since then endovascular embolization has become effective and in some cases preferred method of treatment of intracranial aneurysms A 2005 randomized multicenter study titled International Subarachnoid Aneurysm Trial ISAT demonstrated that in comparison to surgical clipping endovascular repair clinical outcomes result in significant risk reduction and long-term independence post-procedure To verify their findings the ISAT authors reviewed the clinical outcomes at 1 year of 1063 of 1072 patients who underwent ruptured aneurysm embolization using detachable coils compared to 1055 of 1070 who were designated to neurosurgical clipping At the one-year mark patients who experienced endovascular repair demonstrated poor prognosis with less frequency as measured by mortality and extent of dependency in 235 of cases in comparison to 309 of subjects treated via neurosurgical intervention While the results seem to show a considerable preference for embolization the patients in this designated sample were found to experience rebleeds at a higher frequency Beyond resurgence of hemorrhaging embolization risks include aneurysm perforation andor rupture thromboembolic events and coil herniation out of the occluded site Despite the aforementioned risk factors it has become clear that embolization with detachable coils is a much safer treatment option as the rate of procedure-related complications is relatively low This is true for patients with unruptured and ruptured intracranial aneurysms-size and location did not show any statistically significant impact
The study will enroll approximately 30 subjects to allow us to adequately observe the benefits of the central limit theorem Based on prior experience we expect that approximately 10 of all participants may be lost to follow-up andor will withdraw from the study It is estimated that two years are needed to complete the study The first year will be necessary to enroll 30 subjects and the second year will be necessary to complete the 12-month follow-up visits and study close out procedures The device is to be used per Instructions for Use as indicated for treatment of intracranial aneurysms by way of coil embolization Participating in this study will not contribute or be of detriment in any way of a subjects medical care All study related data gathering activities are standard of care and do not require any special actions
The first-ever recorded use of coils in the treatment of intracranial aneurysms by way of endovascular intervention was in 1988 In 1989 detachable coils were designed by Guido Guglielmi an endovascular neurosurgeon who pioneered the concept of coil embolization Since then endovascular embolization has become effective and in some cases preferred method of treatment of intracranial aneurysms A 2005 randomized multicenter study titled International Subarachnoid Aneurysm Trial ISAT demonstrated that in comparison to surgical clipping endovascular repair clinical outcomes result in significant risk reduction and long-term independence post-procedure To verify their findings the ISAT authors reviewed the clinical outcomes at 1 year of 1063 of 1072 patients who underwent ruptured aneurysm embolization using detachable coils compared to 1055 of 1070 who were designated to neurosurgical clipping At the one-year mark patients who experienced endovascular repair demonstrated poor prognosis with less frequency as measured by mortality and extent of dependency in 235 of cases in comparison to 309 of subjects treated via neurosurgical intervention While the results seem to show a considerable preference for embolization the patients in this designated sample were found to experience rebleeds at a higher frequency Beyond resurgence of hemorrhaging embolization risks include aneurysm perforation andor rupture thromboembolic events and coil herniation out of the occluded site Despite the aforementioned risk factors it has become clear that embolization with detachable coils is a much safer treatment option as the rate of procedure-related complications is relatively low This is true for patients with unruptured and ruptured intracranial aneurysms-size and location did not show any statistically significant impact
The study will enroll approximately 30 subjects to allow us to adequately observe the benefits of the central limit theorem Based on prior experience we expect that approximately 10 of all participants may be lost to follow-up andor will withdraw from the study It is estimated that two years are needed to complete the study The first year will be necessary to enroll 30 subjects and the second year will be necessary to complete the 12-month follow-up visits and study close out procedures The device is to be used per Instructions for Use as indicated for treatment of intracranial aneurysms by way of coil embolization Participating in this study will not contribute or be of detriment in any way of a subjects medical care All study related data gathering activities are standard of care and do not require any special actions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None