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.
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 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 18 European Institutions. The expected approximate study duration is 39 months.
Study Type
OBSERVATIONAL
Enrollment
20
Rigshospitalet University
Copenhagen, Denmark
CHU Pellgrin
Bordeaux, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Overall cure rate
Time frame: immediately after final embolization
Cure rate with regard to the aim of the endovascular treatment
Time frame: immediately after final embolization
Overall cure rate
Time frame: 3-6 months
Cure rate with regard to the aim of the endovascular treatment
Time frame: 3-6 months
Clinical outcome compared to baseline
Assessment by mRS
Time frame: up to 3 days
Clinical outcome compared to baseline
Assessment by mRS
Time frame: 1 month after each embolization
Clinical outcome compared to baseline
Assessment by mRS
Time frame: 3-6 months after the final embolization
Adverse Events
AE related to the PHIL procedure and/or to the techniques used during each embolization
Time frame: 1 months after last embolization
Total volume of injected PHIL
Time frame: during each embolization
Volume/superselective injection
Time frame: during each embolization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU Limoges
Limoges, France
La Fondation Rothschild
Paris, France
Hôpital Pierre Paul Riquet
Toulouse, France
Hospital Universitario General de Catalunya
Barcelona, Spain
Hospital Nuestra Senora del Rosario
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
...and 6 more locations
Length of reflux of PHIL
Time frame: during each embolization
Amount of pedicles catheterized
Time frame: during each embolization
Overall injection time
Time frame: during each embolization
Overall radiation dose given to the patient during EVT
Time frame: during each embolization