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

• ClinicalTrials.gov Identifier: NCT03341039
• Recruitment Status: Terminated
• First Posted: November 14, 2017
• Last Update Posted: July 29, 2021
• Sponsor: Microvention-Terumo, Inc.
• Collaborator: ClinSearch
• Information provided by (Responsible Party): Microvention-Terumo, Inc.

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 15 Months
• Official Title: PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study
• Actual Study Start Date: November 14, 2017
• Actual Primary Completion Date: October 14, 2020
• Actual Study Completion Date: October 14, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Overall cure rate [ Time Frame: immediately after final embolization ]
2. Cure rate with regard to the aim of the endovascular treatment [ Time Frame: immediately after final embolization ]
3. Overall cure rate [ Time Frame: 3-6 months ]
4. Cure rate with regard to the aim of the endovascular treatment [ Time Frame: 3-6 months ]
5. Clinical outcome compared to baseline [ Time Frame: up to 3 days ]
   Assessment by mRS
6. Clinical outcome compared to baseline [ Time Frame: 1 month after each embolization ]
   Assessment by mRS
7. Clinical outcome compared to baseline [ Time Frame: 3-6 months after the final embolization ]
   Assessment by mRS

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: 1 months after last embolization ]
   AE related to the PHIL procedure and/or to the techniques used during each embolization
2. Total volume of injected PHIL [ Time Frame: during each embolization ]
3. Volume/superselective injection [ Time Frame: during each embolization ]
4. Length of reflux of PHIL [ Time Frame: during each embolization ]
5. Amount of pedicles catheterized [ Time Frame: during each embolization ]
6. Overall injection time [ Time Frame: during each embolization ]
7. Overall radiation dose given to the patient during EVT [ Time Frame: during each embolization ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

Denmark

Rigshospitalet University

Copenhagen, Denmark, 2100

France

CHU Pellgrin

Bordeaux, France, 33000

Hôpital Bicêtre

Le Kremlin-Bicêtre, France, 94270

CHU Limoges

Limoges, France, 87000

La Fondation Rothschild

Paris, France, 75010

Hôpital Pierre Paul Riquet

Toulouse, France, 31059

Spain

Hospital Universitario General de Catalunya

Barcelona, Spain, 08190

Hospital Nuestra Senora del Rosario

Madrid, Spain, 28006

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain, 30120

Hospital Regional Universitario Carlos Haya

Málaga, Spain, 29010

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Sweden

Universitetssjukhus Umea

Umeå, Sweden, 90746

Uppsala University

Uppsala, Sweden, 75185

United Kingdom

University Hospital Birmingham

Birmingham, United Kingdom, B15 2TH

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Charing Cross Hospital

London, United Kingdom, W 8RF

Sponsors and Collaborators

Microvention-Terumo, Inc.

ClinSearch

More Information

Additional Information:

• Responsible Party: Microvention-Terumo, Inc.
• ClinicalTrials.gov Identifier: NCT03341039
• Other Study ID Numbers: cAVM-PHIL Registry
• First Posted: November 14, 2017
• Last Update Posted: July 29, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Intracranial Arteriovenous Malformations; Arteriovenous Malformations; Congenital Abnormalities; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Intracranial Arterial Diseases