Status:
COMPLETED
PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF
Lead Sponsor:
Microvention-Terumo, Inc.
Collaborating Sponsors:
ClinSearch
Conditions:
Dural Arteriovenous Fistula
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
Detailed Description
This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care. The objective of this study is to evaluate the efficacy and safety of the P...
Eligibility Criteria
Inclusion
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
- Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
- Patient is at least 18 years of age.
Exclusion
- Patient has multiple dAVFs to be treated.
- Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
- Patient does not give consent to the collection and processing of data required for centralized monitoring
- 3\. Any condition that could prevent patient follow up.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03317821
Start Date
September 18 2017
End Date
March 11 2020
Last Update
July 29 2021
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet University
Copenhagen, Denmark, 2100
2
CHU Pellgrin
Bordeaux, France, 33000
3
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
4
CHU Limoges
Limoges, France, 87000