NCT03341039

PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)

PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cerebral AV Malformation

Timeline

• Start date: 2017-11-14
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2017-11-14
• Last updated: 2021-07-29

Locations

16 sites across 5 countries: Denmark, France, Spain, Sweden, United Kingdom