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
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 18-000963
NCT ID: NCT03383666
Sponsor Protocol Number: CLIN-0034
About this study
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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
- 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.)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Giuseppe Lanzino, M.D.
Closed for enrollment
Publications are currently not available