Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
ConditionAneurysm Cerebral
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-80
SponsorNVMedTech
About this trial
To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches
Eligibility criteria
Qualifiers
Is located on the internal carotid artery or its branch-es.
Has a neck ≥ 4 mm, dome to neck ratio < 2.0, or no discernible neck
Aneurysm diameter ≤ 35 mm (saccular or fusiform configuration)
Has a parent vessel diameter ≥ 2.0 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed.
Disqualifiers
Has an extradural aneurysm
Has a target aneurysm in the posterior circulation
Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study)
Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
Trial design
Treatments tested in this trial
- TUBE Flow Diverter
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov