Brain Aneurysm Clinical Trial
Official title:
Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms.
Primary Endpoints:
Safety: Death or stroke in downstream territory to 180-days post-procedure Technical Success:
Device placement success and ability to retain coils within the aneurysm (as judged by the
treating physician at the time of the procedure. Core lab will review images at a later time)
Rate of aneurysm occlusion at Day zero (0) and 180-days
Additional Evaluations to 180-days and at 365-day follow up Rate of aneurysm occlusion at 365
days Device movement or migration defined as any relative change in the position of the
device with respect to the parent and/or daughter vessels that is greater than 2mm by
conventional catheter angiography, CTA or MRA (180 days) and (365 days) Stenosis defined as
>50% at implant site by conventional catheter angiography, MRA or CTA at 180 days and at 365
days Rate of incidence of new neurological deficits Complication rate (neurological and
non-neurological)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02345395 -
Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
|
N/A | |
| Active, not recruiting |
NCT05626504 -
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
|
||
| Completed |
NCT01716117 -
Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
|
N/A | |
| Completed |
NCT04553549 -
Safety and Feasibility of the Infinity Catheter for Radial Access
|
||
| Completed |
NCT04439760 -
Superior Cervical Ganglion Block, Transcranial Doppler
|
N/A | |
| Completed |
NCT01975233 -
WEB French Observatory of the WEB Aneurysm Embolization System
|
||
| Terminated |
NCT01557036 -
Aneurysm Study of Pipeline in an Observational Registry
|
N/A | |
| Completed |
NCT03844334 -
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
|
||
| Active, not recruiting |
NCT03852680 -
Current Treatment Modalities for Wide Necked Intracranial Aneurysms
|
N/A | |
| Completed |
NCT01444664 -
Aneurysm Wall Histology Registry
|
Phase 4 | |
| Recruiting |
NCT03936647 -
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
|
N/A | |
| Completed |
NCT02687607 -
CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
|
||
| Withdrawn |
NCT02037932 -
Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
|
Phase 4 | |
| Recruiting |
NCT06456814 -
Epidemiological Insights Into the Formation, Progression, and Rupture of Intracranial Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
|
||
| Recruiting |
NCT05317169 -
Aneurysm Genetic Risk in Patients With QIB Changes
|
||
| Terminated |
NCT00537134 -
Trial on Endovascular Aneurysm Management
|
N/A |