The objective of this prospective, nonrandomized, international, FDA approved, multi-center Study is to confirm the clinical experience in Europe and demonstrate the safety and efficacy of the Elana Arteriotomy System in creating an intracranial arteriotomy in a nonocclusive manner.
Centers will enroll patients who require a temporary or permanent bypass to be connected to one or more unoccluded intracranial vessel(s) for an established indication and for whom the responsible surgeon feels they cannot be safely treated otherwise e.g., because of a lesion not ideal for coiling or clipping or excision or temporary or permanent occlusion of a vessel without the temporary or permanent creation of a bypass.
Physicians within the referral areas of the participating centers are being asked for their help in identifying patients who meet the inclusion/exclusion criteria.
| US Sites | European Sites |
| Facility: St. Lukes Roosevelt Hospial, New York, NY Clinical Investigator(s): D.J. Langer, Neurosurgeon Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +1 212 636 3204 |
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Facility: University of Illinois, Chicago, IL Clinical Investigator(s): F. Charbel & S. Amin-Hanjani, Neurosurgeons Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it ; This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +1 312 996 4842 | Facility: Helsinki University Hospital, Helsinki, Finland Clinical Investigator(s): L. Kivipelto & M. Lehecka, Neurosurgeons Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +358 9 471 75 397 |
Facility: University of Arkansas UAMS, Little Rock, AR Clinical Investigator(s): A. Krisht, Neurosurgeon Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +1 501 296 1463 | Facility: University Medical Center, Utrecht, the Netherlands Clinical Investigator(s): A. van der Zwan, Neurosurgeon Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +31 30 250 97 75 |
Facility: L.M. Miller School of Medicine, University of Miami, Miami, Florida (in progress of enrollment) Clinical Investigator(s): J. Morcos, Neurosurgeon Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +1 305 243 4675 |
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Facility: University of Texas Southwestern Medical Center, Dallas, Texas Clinical Investigator(s): D. Samson B. & Welch, neurosurgeons Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Phone: +1 214 648 3928 | Canadian Sites Facility: Toronto Western Hospital,Toronto Canada (in progress of enrollment) |
For more information about the Elana study, please visit http://www.elana-study.com/
