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

Overview

About this study

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

Participation eligibility

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.

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.)

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 Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Giuseppe Lanzino, M.D.

Closed for enrollment

Contact information:

Yeoniee Kim

(507) 266-6585

Kim.Yeoniee@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20425287

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