Intracranial Aneurysm Clinical Trial
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.
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.
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). ;
| 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| Withdrawn |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 |
NCT00777088 -
Pipeline for Uncoilable or Failed Aneurysms
|
N/A | |
| Completed |
NCT00777907 -
Complete Occlusion of Coilable Aneurysms
|
Phase 3 |