A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm (NAPA)
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|ClinicalTrials.gov Identifier: NCT03383666|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Unruptured Wide-neck Intracranial Aneurysms||Device: PulseRider® Aneurysm Neck Reconstruction Device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Treatment Group
PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.
Device: PulseRider® Aneurysm Neck Reconstruction Device
Neck Reconstruction Device
- The Primary Safety Outcome measure is the composite of Neurological Death or Major Ipsilateral Stroke (in downstream territory) up to 1 year post-procedure [ Time Frame: 12 months ]Composite of Neurological Death or Major Ipsilateral Stroke (in downstream territory) up to 1 year post-procedure.
- The primary effectiveness rate of complete aneurysm occlusion without significant parent artery stenosis or prior retreatment at 1 year post-procedure. [ Time Frame: 12 months ]The primary effectiveness rate of complete aneurysm occlusion without significant parent artery stenosis or prior retreatment at 1 year post-procedure.
- Technical Success is measured by the successful implantation of the device. [ Time Frame: Procedural ]The successful implantation of the device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383666
|Contact: Lisa Park||949-450-6801||RA-BWIUS-PulseRider@ITS.JNJ.com|
|Contact: Christopher Hendricks||949-450-6801||RA-BWIUS-PulseRider@ITS.JNJ.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Eric Begemann|