Status:
TERMINATED
Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
Lead Sponsor:
Medical Therapy Solutions
Collaborating Sponsors:
Archer Research
Conditions:
Ruptured and Unruptured Intracranial Aneurysms
Eligibility:
All Genders
18-80 years
Brief Summary
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood f...
Eligibility Criteria
Inclusion
- Patient is between 18 and 80 years old.
- Patient must sign and date the informed consent form \<72hrs post-procedure and prior to data registration. If patient is not able to give informed consent for himself/herself, a legally authorized representative must give informed consent on his/her behalf.
- Patient has a ruptured (Hunt and Hess grades 1, 2 or 3) or unruptured intracranial aneurysm requiring endovascular treatment.
- Aneurysm with dome-to-neck ratio ≥ 1.
Exclusion
- Aneurysm size unfavourable for WEB implantation (aneurysm width \> 10 mm or aneurysm width \< 3mm).
- Patient with Hunt and Hess grades 4 or 5.
- Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
- Parent vessel occlusion.
Key Trial Info
Start Date :
February 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03312725
Start Date
February 1 2017
End Date
June 26 2018
Last Update
October 10 2018
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium