Intracranial Aneurysms
Conditions
Brief summary
This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
Detailed description
Primary Endpoints: * Safety: Death or stroke in downstream territory to 180-days post-procedure * Technical Success: Device placement success and ability to retain coils at the time of the index procedure * 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 * Stenosis * Rate of incidence of new neurological deficits * Complication rate (neurological and non-neurological)
Interventions
DEVICEPulseRider
Adjunctive device for endovascular embolization of intracranial aneurysms
Sponsors
Pulsar Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who presents with an angiographically confirmed, wide neck intracranial aneurysms located at a bifurcation of the basilar artery or carotid terminus artery * The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm. * The patient is 18 years or older at the time of consent * The patient has signed the IRB/EC approved informed consent form * In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated * Subject has mental capacity and is willing and able to comply with protocol requirements and follow-up
Exclusion criteria
* Unstable neurological deficit (condition worsening within the last 90 days) * Subarachnoid Hemorrhage (SAH) within the last 60 days * Irreversible bleeding disorder * mRS score ≥3 * Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days) * Platelet count \< 100 x 103 cells/mm3 * Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel * A history of contrast allergy that cannot be medically controlled * Known allergy to nickel * Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL) * Woman with child-bearing potential who cannot provide a negative pregnancy test * Evidence of active infection * Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events * Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 365-day follow-up period * Extracranial stenosis greater than 50% in the parent artery requiring access to the lesion * Intracranial stenosis greater than 50% in the treated vessel * Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire and/or the PulseRider delivery wire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death | 180 days post procedure | Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PulseRider Total Participants | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | PulseRider |
|---|---|
| Age, Continuous Age | 60.9 year STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 27 / 34 |
| serious Total, serious adverse events | 12 / 34 |
Outcome results
Primary
Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death.
Time frame: 180 days post procedure
Population: One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety | Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death | # participants who scored Raymond Score I/II | 29 Participants |
| Safety | Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death | # participants experienced Neurological Death | 0 Participants |