NCT05330897

French eCLIPs™ Efficacy and Safety Investigation

A Multicentre Post Marketing Study in France Evaluating the Safety and Efficacy of the eCLIPs™ Family of Products for the Treatment of Bifurcation Intracranial Aneurysms at the Carotid and Basilar Terminus

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sponsor: Evasc Medical Systems Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.

Detailed description

This study is a multicentre, open label, historically controlled, single-arm safety and efficacy study of the eCLIPs™ products in the management of bifurcated intracranial aneurysms at basilar tip and carotid terminus. Patients with basilar tip and carotid terminus aneurysms are not considered suitable for surgical treatment by the neurovascular community because of the poor outcome in these localizations. Patients 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 dome:neck ratio \<2. Efficacy will be measured as the proportion of aneurysms achieving complete occlusion (Raymond-Roy 1) at 12 months, while safety will be measured as the proportion of patients without a major stroke or non-accidental death within 30 days (procedural) and without a major ipsilateral stroke or neurological death between 31 days and 12 months. Additional endpoints will be evaluated and data collected to assess safety and collect information on the eCLIPs™ family of products.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Implantation of an eCLIPs™ device	Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm
DEVICE	eCLIPs™ Electrolytic Bifurcation Systems	Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Timeline

• Start date: 2021-12-16
• Primary completion: 2025-12-16
• Completion: 2026-12-16
• First posted: 2022-04-15
• Last updated: 2025-08-15

Locations

28 sites across 1 country: France