Status:
TERMINATED
PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)
Lead Sponsor:
Microvention-Terumo, Inc.
Collaborating Sponsors:
ClinSearch
Conditions:
Cerebral AV Malformation
Eligibility:
All Genders
28+ years
Brief Summary
The primary objective of this study is to assess the efficacy and safety of PHIL® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.
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
- All patients with a ruptured or unruptured and previously endovascularly untreated cAVM that are eligible for endovascular treatment with PHIL® alone or in conjunction with N-Butyl cyanoacrylate glue (NBCA) and/or coils (e.g. if "pressure cooking" technique is needed or used).
- All patients with a previously endovascularly treated cAVM in which NBCA and/or coils (but not another non-adhesive liquid embolic agent) have been used may be included.\*\*
- All patients with a remaining cAVM, ruptured or unruptured, that has previously been treated with NS and/or RT may be included.
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form. (Based on the country's regulation).
Exclusion
- cAVM not eligible for endovascular treatment
- cAVM previously treated with a non-adhesive liquid embolic agent other than PHIL®
- Treatment requiring the use of any other non-adhesive embolic liquid
- Patient is allergic to iodine
- Premature and newborn infant
- Patient with renal failure or significant liver impairment
- Patient is participating in another study evaluating other medical devices, other procedures or medications.
- Any other condition that might prevent patient participation in the study or follow up
- Patient does not want to and/or refuses to give consent to the collection and processing of data required for centralized monitoring
Key Trial Info
Start Date :
November 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03341039
Start Date
November 14 2017
End Date
October 14 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