Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction (ANSWER)

Pulsar Vascular

Status

Completed

Conditions

Intracranial Aneurysms

Treatments

Device: PulseRider

Study type

Interventional

Funder types

Industry

Identifiers

NCT02312856

CLIN-0014

Details and patient eligibility

About

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.

Full 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)

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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