Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
This trial is active, not recruiting.
|Start date||October 2014|
|End date||October 2016|
|Trial size||30 participants|
|Trial identifier||NCT02312856, CLIN-0014|
This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
|Intervention model||single group assignment|
Endovascular treatment of intracranial aneurysms
Death or stroke in downstream territory
time frame: 180-days post-procedure
ability to retain coils within the aneurysm
time frame: time of procedure
Male or female participants at least 18 years old.
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
|Official title||Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and|
|Principal investigator||Alejandro Spiotta, MD|
|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)|
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