Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Completed · Not applicable

Conditions studied: Intracranial Aneurysms

In brief

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

Key facts

Study ID

NCT02312856

Run by

Pulsar Vascular

People needed

34

Starts

2014-10-31

Expected to finish

2016-10-30

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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