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

Terminated

• Conditions: Cerebral AV Malformation

• Registration Number: NCT03341039
• Lead Sponsor: Microvention-Terumo, Inc.

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 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 Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-11-08
• Study Start: 2017-11-14
• Study First Posted: 2017-11-14
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 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).
2. 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.**
3. All patients with a remaining cAVM, ruptured or unruptured, that has previously been treated with NS and/or RT may be included.
4. 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 Criteria

1. cAVM not eligible for endovascular treatment
2. cAVM previously treated with a non-adhesive liquid embolic agent other than PHIL®
3. Treatment requiring the use of any other non-adhesive embolic liquid
4. Patient is allergic to iodine
5. Premature and newborn infant
6. Patient with renal failure or significant liver impairment
7. Patient is participating in another study evaluating other medical devices, other procedures or medications.
8. Any other condition that might prevent patient participation in the study or follow up
9. Patient does not want to and/or refuses to give consent to the collection and processing of data required for centralized monitoring

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate with regard to the aim of the endovascular treatment	3-6 months
Clinical outcome compared to baseline	3-6 months after the final embolization	Assessment by mRS
Overall cure rate	3-6 months

Secondary Outcome Measures

Name	Time	Method
Overall radiation dose given to the patient during EVT	during each embolization
Overall injection time	during each embolization
Adverse Events	1 months after last embolization	AE related to the PHIL procedure and/or to the techniques used during each embolization
Total volume of injected PHIL	during each embolization
Volume/superselective injection	during each embolization
Amount of pedicles catheterized	during each embolization
Length of reflux of PHIL	during each embolization

Trial Locations

Locations (16)

Hospital Nuestra Senora del Rosario; 🇪🇸 Madrid, Spain

La Fondation Rothschild; 🇫🇷 Paris, France

Hospital Universitario General de Catalunya; 🇪🇸 Barcelona, Spain

Hospital Regional Universitario Carlos Haya; 🇪🇸 Málaga, Spain

Universitetssjukhus Umea; 🇸🇪 Umeå, Sweden

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Uppsala University; 🇸🇪 Uppsala, Sweden

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hôpital Pierre Paul Riquet; 🇫🇷 Toulouse, France

CHU Pellgrin; 🇫🇷 Bordeaux, France

CHU Limoges; 🇫🇷 Limoges, France

University Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Hospital Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain

Rigshospitalet University; 🇩🇰 Copenhagen, Denmark

Charing Cross Hospital; 🇬🇧 London, United Kingdom