Status:
COMPLETED
Cascade Clinical Data Collection Protocol
Lead Sponsor:
Perflow Medical
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
Brief Summary
This study is a multi-center, single arm, open label, retrospective and prospective clinical data collection of CascadeTM, Non-Occlusive Remodeling Net, in adults with intracranial aneurysms, demonstr...
Eligibility Criteria
Inclusion
- Patients must fulfill the following eligibility criteria to be included in the study:
- Patient has been treated or planned to be treated with Cascade (Cascade device was opened).
- Patient or patient's legally authorized representative or patient's family member (if approved by IEC) has signed and dated an Informed Consent Form (ICF), unless ICF is waived by local IEC.
- Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated
Exclusion
Key Trial Info
Start Date :
March 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 24 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04760925
Start Date
March 5 2020
End Date
April 24 2022
Last Update
October 4 2022
Active Locations (7)
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1
UH St. Ivan Rilski
Sofia, Bulgaria
2
Medical Faculty of the Otto von Guericke University Magdeburg
Magdeburg, Germany, 39120
3
radprax MVZ GmbH
Solingen, Germany
4
Sheba Medical Center
Tel Litwinsky, Israel