Status:
TERMINATED
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
Lead Sponsor:
Pulsar Vascular
Conditions:
Unruptured Wide-neck Intracranial Aneurysms
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 un...
Eligibility Criteria
Inclusion
- Subject with wide neck intracranial aneurysm located at a bifurcation
- The subject is between 18 and 80 years of age the time of consent
- Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
- In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated
Exclusion
- Unstable neurological deficit (condition worsening within the last 90 days)
- Subarachnoid Hemorrhage (SAH) within the last 60 days
- Irreversible bleeding disorder
- Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
- A history of contrast allergy that cannot be medically controlled
- Known allergy to nickel
- Relative contraindication to angiography
- Woman of child-bearing potential who cannot provide a negative pregnancy test
- Current involvement in a study for another investigational product
- Patient and / or family considering a move from this geographical location at the time of consent
- Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03383666
Start Date
October 15 2018
End Date
April 12 2021
Last Update
June 6 2023
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Mount Sinai Hospital
New York, New York, United States, 10029