Status:
COMPLETED
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
Lead Sponsor:
Pulsar Vascular
Conditions:
Intracranial Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
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 proc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02312856
Start Date
October 31 2014
End Date
October 30 2016
Last Update
April 17 2019
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425