Safety & Performance of the World Medica World Diverter Embolization Device
NCT07339358 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2026-01-14
Summary
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.
Conditions
- Intracranial Aneurysm
Interventions
- DEVICE
-
Flow diverter implantation
Implantation of the World Diverter Embolization Device
Sponsors & Collaborators
-
World Medica USA, LLC
lead INDUSTRY
Principal Investigators
-
Alejandro Tomasello, MD · Hospital Vall d'Hebron
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2028-03-31
- Completion
- 2028-08-31
- FDA Device
- Yes
Countries
- Spain
Study Locations
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