NCT02607501

European eCLIPS™ Safety, Feasibility and Efficacy Study

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Evasc Medical Systems Corp. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Saccular Aneurysm
• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Implant eCLIPs	Implant eCLIPs at target bifurcation aneurysm

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-01-31
• Completion: 2021-09-30
• First posted: 2015-11-18
• Last updated: 2022-11-29

Locations

4 sites across 3 countries: Denmark, Germany, Netherlands