Unruptured Wide-neck Intracranial Aneurysms Clinical Trial
— NAPAOfficial 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
| Verified date | June 2023 |
| Source | Pulsar Vascular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
| Status | Terminated |
| Enrollment | 21 |
| Est. completion date | April 12, 2021 |
| Est. primary completion date | April 12, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: 1. Subject with wide neck intracranial aneurysm located at a bifurcation 2. The subject is between 18 and 80 years of age the time of consent 3. Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures 4. In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated Exclusion Criteria: 1. Unstable neurological deficit (condition worsening within the last 90 days) 2. Subarachnoid Hemorrhage (SAH) within the last 60 days 3. Irreversible bleeding disorder 4. Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period 5. A history of contrast allergy that cannot be medically controlled 6. Known allergy to nickel 7. Relative contraindication to angiography 8. Woman of child-bearing potential who cannot provide a negative pregnancy test 9. Current involvement in a study for another investigational product 10. Patient and / or family considering a move from this geographical location at the time of consent 11. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.) |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Mount Sinai Hospital | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Pulsar Vascular |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure | Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than [>] 50 percent [%] stenosis) or prior retreatment through 1-year post procedure were reported. | Up to 1 year post procedure | |
| Primary | Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC) | Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (>=) 4. Major ipsilateral stroke is major stroke in downstream territory. | Up to 1 year post procedure | |
| Secondary | Number of Participants With Technical Success of Successful Implantation of the PulseRider Device | Technical success was defined as successful implantation of the PulseRider device- the ability to access the target aneurysm, deploy the device at the aneurysm neck, and detach device successfully. Number of participants with technical success were reported. | Up to 1 year | |
| Secondary | Number of Participants With Target Aneurysms Retreatment | Number of participants with target aneurysms retreatment were reported. | Up to 1 year | |
| Secondary | Number of Participants With Significant Stenosis (>50%) at Implant Site | Number of participants with significant stenosis (>50%) at implant site were reported. | Up to 1 year | |
| Secondary | Number of Participants With Adequate Aneurysm Occlusion | Number of participants with adequate aneurysm occlusion were reported. | 1 year | |
| Secondary | Number of Participants With Modified Rankin Scale (mRS) 0-2 | Number of participants with modified rankin scale (mRS) 0-2 were reported. The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in patients following stroke or other neurologic event and is conducted by qualified personnel. It is a scale with six categories ranging from no symptoms to severe disability and death. | 1 year |