Trials / Terminated
TerminatedNCT03383666
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
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Pulsar Vascular · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
Detailed description
The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PulseRider® Aneurysm Neck Reconstruction Device | Neck Reconstruction Device |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2021-04-12
- Completion
- 2021-04-12
- First posted
- 2017-12-26
- Last updated
- 2023-06-06
- Results posted
- 2022-04-14
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03383666. Inclusion in this directory is not an endorsement.