Unruptured Wide-neck Intracranial Aneurysms
Conditions
Keywords
Unruptured, intracranial aneurysms, Endovascular
Brief 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.
Interventions
DEVICEPulseRider® Aneurysm Neck Reconstruction Device
Neck Reconstruction Device
Sponsors
Pulsar Vascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure | Up to 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. |
| 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) | Up to 1 year post procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Significant Stenosis (>50%) at Implant Site | Up to 1 year | Number of participants with significant stenosis (\>50%) at implant site were reported. |
| Number of Participants With Technical Success of Successful Implantation of the PulseRider Device | Up to 1 year | 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. |
| Number of Participants With Modified Rankin Scale (mRS) 0-2 | 1 year | 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. |
| Number of Participants With Adequate Aneurysm Occlusion | 1 year | Number of participants with adequate aneurysm occlusion were reported. |
| Number of Participants With Target Aneurysms Retreatment | Up to 1 year | Number of participants with target aneurysms retreatment were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PulseRider Aneurysm Neck Reconstruction Device Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | PulseRider Aneurysm Neck Reconstruction Device |
|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 10.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 13 / 21 |
| serious Total, serious adverse events | 5 / 21 |
Outcome results
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.
Time frame: Up to 1 year post procedure
Population: The Per Protocol (PP) analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure | 10 Participants |
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.
Time frame: Up to 1 year post procedure
Population: The modified intent to treat (mITT) analysis set is defined as all enrolled participants in whom treatment with the PulseRider device was attempted as defined by advancement of any portion of the PulseRider device outside of the distal end of the microcatheter inside the participant. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | 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) | Major Ipsilateral Stroke in Downstream Territory | 0 Percentage of Participants |
| PulseRider Aneurysm Neck Reconstruction Device | 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) | Neurological Death | 0 Percentage of Participants |
Secondary
Number of Participants With Adequate Aneurysm Occlusion
Number of participants with adequate aneurysm occlusion were reported.
Time frame: 1 year
Population: The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | Number of Participants With Adequate Aneurysm Occlusion | 13 Participants |
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.
Time frame: 1 year
Population: The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations from the eligibility criteria or dual antiplatelet medication. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | Number of Participants With Modified Rankin Scale (mRS) 0-2 | 12 Participants |
Secondary
Number of Participants With Significant Stenosis (>50%) at Implant Site
Number of participants with significant stenosis (\>50%) at implant site were reported.
Time frame: Up to 1 year
Population: The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | Number of Participants With Significant Stenosis (>50%) at Implant Site | 0 Participants |
Secondary
Number of Participants With Target Aneurysms Retreatment
Number of participants with target aneurysms retreatment were reported.
Time frame: Up to 1 year
Population: The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations from the eligibility criteria or dual antiplatelet medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | Number of Participants With Target Aneurysms Retreatment | 0 Participants |
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.
Time frame: Up to 1 year
Population: The mITT analysis set is defined as all enrolled participants in whom treatment with the PulseRider device was attempted as defined by advancement of any portion of the PulseRider device outside of the distal end of the microcatheter inside the participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PulseRider Aneurysm Neck Reconstruction Device | Number of Participants With Technical Success of Successful Implantation of the PulseRider Device | 18 Participants |