Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Not Applicable

Completed

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)

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PulseRider aneurysm	PulseRider	Endovascular treatment of intracranial aneurysms

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures