Safety & Performance of the World Medica World Diverter Embolization Device
ConditionIntracranial Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorWorld Medica USA, LLC
About this trial
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \<2) or fusiform intracranial aneurysms in the internal carotid artery (ICA) from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.
Eligibility criteria
Qualifiers
Age 18 22 to 80 years
Subject, or subject's legal representative provided informed consent
Subject agrees to the requirements of the study, including returning for required follow-up visits
Parent artery diameter of 2.0-5.5 mm distal and proximal to the target IA
Disqualifiers
A subarachnoid or intracerebral hemorrhage in the 60 days preceding the index procedure
A bleeding disorder or a platelet count of less than 100x103/mm3 or INR >1.5
A contraindication to or inability to tolerate antiplatelet therapy
An allergy to radiographic contrast agents
Trial design
Treatments tested in this trial
- Flow diverter implantation
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov