Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02607501
Study type Interventional
Source Evasc Medical Systems Corp.
Contact
Status Terminated
Phase N/A
Start date April 1, 2016
Completion date September 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04870047 - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT05665309 - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor N/A
Completed NCT02783339 - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn NCT01194388 - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05409989 - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study N/A
Completed NCT03680742 - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm N/A
Completed NCT04872842 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated NCT02532517 - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device N/A
Completed NCT03663257 - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Recruiting NCT05608122 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting NCT03661463 - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT). Phase 2
Completed NCT02609867 - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise) N/A
Active, not recruiting NCT02292017 - Prospective Packing Density With Target Coils I N/A
Active, not recruiting NCT01872741 - Minipterional Versus Pterional Craniotomy N/A
Completed NCT00993057 - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia Early Phase 1
Completed NCT00777907 - Complete Occlusion of Coilable Aneurysms Phase 3
Completed NCT00777088 - Pipeline for Uncoilable or Failed Aneurysms N/A