cAVM-Phil Registry
Research type
Research Study
Full title
PHIL evaluation in the endovascular treatment of intracranial cerebral ArterioVenous Malformation (cAVM)
IRAS ID
236834
Contact name
Saleh LAMIN
Contact email
Sponsor organisation
Microvention Europe
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
This is an observational study. Treatments and follow-up visits will be done as per standard of care. There are no additional procedures or tests.
The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial cerebral arteriovenous malformation. The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.
All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus are eligible for this study. A maximum of 108 patients will be enrolled in this study in 18 European Institutions.
The expected approximate study duration is 39 months.
As this is an observational study with no additional procedures to standard of care, only patients medical data will be collected.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0107
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion