Status:
UNKNOWN
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
Lead Sponsor:
Kaneka Corporation
Collaborating Sponsors:
ClinSearch
Conditions:
Aneurysm
Arteriovenous Malformations
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and...
Eligibility Criteria
Inclusion
- Patients are over 18 years of age.
- Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
- The patient, or his/her representative, has agreed to the informed consent.
Exclusion
- The patient, or his/her representative, is unwilling or unable to agree to the informed consent.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03853070
Start Date
December 11 2018
End Date
December 1 2021
Last Update
February 25 2019
Active Locations (3)
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1
UZA Atwerp
Edegem, Antwerp, Belgium, 2650
2
Knappschaftskrankenhaus Bochum
Bochum, North Rhine-Westphalia, Germany, 44892
3
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538