Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02607501
Status:
TERMINATED
Last Update Posted:
2022-11-29
First Post:
2015-11-16
Brief Title:
European eCLIPS Safety Feasibility and Efficacy Study
Sponsor:
Evasc Medical Systems Corp
Organization:
Evasc Medical Systems Corp
Study Overview
Official Title:
A Multi-center Post Marketing Study Evaluating the Safety Technical Feasibility and Efficacy of the eCLIPs Family of Products for the Treatment of Bifurcation Intracranial Aneurysms
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EESIS
Brief Summary:
An open label prospective multicentre single-arm post marketing study evaluating the safety technical feasibility and efficacy of the eCLIPs Family of Products for the treatment of bifurcation intracranial aneurysms
Detailed Description:
The objective of this study is to obtain data on the technical feasibility safety and efficacy of the eCLIPs Products for the treatment of bifurcation aneurysms Specifically procedural success of the eCLIPs Bifurcation Remodelling System BRS will be evaluated to determine feasibility of this product and safety will be measured as of a major stroke or death within 30 days or major territorial stroke or neurological death within one year Additional endpoints will be evaluated and data collected to assess the procedural success of the other eCLIPs Products Microcatheter Microintroducer Detacher and collect efficacy information on the eCLIPs Products A rate of 69 of aneurysms achieving Raymond Class 1 occlusion at the 12 month endpoint has been chosen as the criterion for success in subjects treated with the eCLIPs Device and coils primary endpoint
An upper 95 confidence interval of 10 rate of major ipsilateral stroke or death at the 1 month and 12 month endpoint has been chosen to demonstrate clinically safety primary endpoint
An upper 95 confidence interval of 10 rate of major ipsilateral stroke or death at the 1 month and 12 month endpoint has been chosen to demonstrate clinically safety primary endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None