Clinical trial NCT03383666: A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Official title: A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Unruptured Wide-neck Intracranial Aneurysms
Keywords: Unruptured
intracranial aneurysms
Endovascular
Lead sponsor: Pulsar Vascular
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.

Detailed description: The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.

Eligibility criteria: Inclusion Criteria:

1. Subject with wide neck intracranial aneurysm located at a bifurcation
2. The subject is between 18 and 80 years of age the time of consent
3. Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
4. In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated

Exclusion Criteria:

1. Unstable neurological deficit (condition worsening within the last 90 days)
2. Subarachnoid Hemorrhage (SAH) within the last 60 days
3. Irreversible bleeding disorder
4. Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
5. A history of contrast allergy that cannot be medically controlled
6. Known allergy to nickel
7. Relative contraindication to angiography
8. Woman of child-bearing potential who cannot provide a negative pregnancy test
9. Current involvement in a study for another investigational product
10. Patient and / or family considering a move from this geographical location at the time of consent
11. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)

Primary outcomes:
measure: Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure
timeFrame: Up to 1 year post procedure
measure: Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)
timeFrame: Up to 1 year post procedure
Secondary outcomes:
measure: Number of Participants With Technical Success of Successful Implantation of the PulseRider Device
timeFrame: Up to 1 year
measure: Number of Participants With Target Aneurysms Retreatment
timeFrame: Up to 1 year
measure: Number of Participants With Significant Stenosis (>50%) at Implant Site
timeFrame: Up to 1 year
measure: Number of Participants With Adequate Aneurysm Occlusion
timeFrame: 1 year
measure: Number of Participants With Modified Rankin Scale (mRS) 0-2
timeFrame: 1 year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
References: