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

Información sobre este estudio

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

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.)

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Giuseppe Lanzino, M.D.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20425287

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