Status:
WITHDRAWN
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+ 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 at least 18 years old.
- Patient is capable to undergo general anaesthesia.
- Patient must sign and date the informed consent form 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 or unruptured intracranial aneurysm requiring endovascular treatment.
- Aneurysm with dome-to-neck ratio ≥ 1.
- Aneurysm size favourable for WEB implantation (aneurysm width \< 10 mm or aneurysm width \> 3mm).
Exclusion
- Patient is pregnant.
- Patient has renal insufficiency (GRF \< 45 ml/min/1.73 m2).
- Patient is unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03379714
Start Date
January 1 2018
End Date
January 31 2022
Last Update
June 1 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650