The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorphenox Inc.
About this trial
To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.
Eligibility criteria
Qualifiers
Subject is ≥ 18 years
Subject has a mRS ≤2 before the index procedure
Saccular or fusiform morphology
Located in the internal carotid artery and its branches
Disqualifiers
Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
Any other known IA requiring treatment within 3 months post-procedure
Subarachnoid hemorrhage in the past 30 days prior to the index procedure
Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
Trial design
Treatments tested in this trial
- Flow diversion
Treatment groups
214 Participants
are divided into 1 treatment groupLocations
21Arizona
Barrow Neurological Institute85013, Phoenix United States
California
UCSF Medical Center at Mount Zion94143, San Francisco United States
Colorado
University of Colorado Anschutz80045, Aurora United States
Swedish Medical Research Center80113, Englewood United States
Sponsors and collaborators
phenox Inc.
Lead sponsor
Phenox GmbH
Collaborator
Source ClinicalTrials.gov