Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04886505
Status:
WITHDRAWN
Last Update Posted:
2022-04-18
First Post:
2021-05-10
Brief Title:
An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms
Sponsor:
Evasc Medical Systems Corp
Organization:
Evasc Medical Systems Corp
Study Overview
Official Title:
An Early Feasibility Study Assessing the Safety Technical Performance and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms The eCLIPs device is a novel shield like implant that is placed across the neck of the aneurysm and not only facilitates coil retention but also partly obstructs the flow of blood into the aneurysm
This is an early feasibility study which is a small study investigating an innovative device to gather more clinical data before conducting a larger study The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms
This is an early feasibility study which is a small study investigating an innovative device to gather more clinical data before conducting a larger study The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms
Detailed Description:
The primary objective of this study is to obtain preliminary confirmation that the eCLIPs Delivery Wire is safe and provides sufficient technical performance in delivering the eCLIPs Implant to distal tortuous anatomies
This study will be a multicentre open label single-arm safety technical performance and efficacy study of the Electrolytic eCLIPs Bifurcation System in the management of bifurcated intracranial aneurysms IA Subjects included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation having a neck length of 4mm or have a domeneck ratio 2 Aside from the implantation of the eCLIPs Implant the study will follow usual clinical care practices
The subjects will undergo clinical assessments at pre-discharge and 30 days as well as clinical assessment and radiographic imaging at 6 and 12 months Digital Subtraction Angiography DSA
It is important to note that changes to the investigational device may occur during the course of this early feasibility study Ongoing results of the study will be evaluated along with collection of detailed operator feedback on usability in order to determine whether further refinements to the eCLIPs Delivery Wire are required
This study will be a multicentre open label single-arm safety technical performance and efficacy study of the Electrolytic eCLIPs Bifurcation System in the management of bifurcated intracranial aneurysms IA Subjects included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation having a neck length of 4mm or have a domeneck ratio 2 Aside from the implantation of the eCLIPs Implant the study will follow usual clinical care practices
The subjects will undergo clinical assessments at pre-discharge and 30 days as well as clinical assessment and radiographic imaging at 6 and 12 months Digital Subtraction Angiography DSA
It is important to note that changes to the investigational device may occur during the course of this early feasibility study Ongoing results of the study will be evaluated along with collection of detailed operator feedback on usability in order to determine whether further refinements to the eCLIPs Delivery Wire are required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None