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

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral AV Malformation

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet University
• France
  • Bordeaux, France, 33000
    • CHU Pellgrin
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Bicêtre
  • Limoges, France, 87000
    • Chu Limoges
  • Paris, France, 75010
    • La Fondation Rothschild
  • Toulouse, France, 31059
    • Hopital Pierre Paul Riquet
• Spain
  • Barcelona, Spain, 08190
    • Hospital Universitario General de Catalunya
  • Madrid, Spain, 28006
    • Hospital Nuestra Señora del Rosario
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Málaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
• Sweden
  • Umeå, Sweden, 90746
    • Universitetssjukhus Umea
  • Uppsala, Sweden, 75185
    • Uppsala University
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospital Birmingham
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, W 8RF
    • Charing Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cure rate		immediately after final embolization
Cure rate with regard to the aim of the endovascular treatment		immediately after final embolization
Overall cure rate		3-6 months
Cure rate with regard to the aim of the endovascular treatment		3-6 months
Clinical outcome compared to baseline	Assessment by mRS	up to 3 days
Clinical outcome compared to baseline	Assessment by mRS	1 month after each embolization
Clinical outcome compared to baseline	Assessment by mRS	3-6 months after the final embolization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Collaborators: ClinSearch

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): October 14, 2020

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: cAVM-PHIL Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No