ClinicalTrials.gg
TerminatedNCT03341039Updated Jul 29, 2021

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

An observational study in Cerebral AV Malformation, sponsored by Microvention-Terumo, Inc.. Terminated at 16 sites in 5 countries. Open to participants aged 28 Days and older. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Observational

Why this study was terminated
Termination of the study due to low enrolment

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
28 Days and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Intracranial Arteriovenous Malformations with a site in France — 6 open to participants now, 6 under way, 1 of them phase 3. Intracranial Arteriovenous Malformations · France.

Started
2017
the only one that year
Observational
6 of 12
3 open now
Registered
3rd of 12
by date
Lead sponsor
1 of 12
Microvention-Terumo, Inc.

Among the 12 studies in Intracranial Arteriovenous Malformations with a site in France, this one is the only one that started in 2017, is one of 6 observational ones, and was the 3rd registered.

Intracranial Arteriovenous Malformations

43 studies on the registry are indexed under Intracranial Arteriovenous Malformations; 15 are open to participants now.

Browse Intracranial Arteriovenous Malformations studies →

Open to participants now

6 of the 12 studies in Intracranial Arteriovenous Malformations with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 11 Intracranial Arteriovenous Malformations studies recruiting now, 8 (73%) set no upper age limit and 2 (18%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.

This study: 28 Days and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Cerebral AV Malformation
04

Who can participate

Ages eligible
28 Days and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form. (Based on the country's regulation).

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
15 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  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

    Assessment by mRS

    Time frame: up to 3 days

  6. Clinical outcome compared to baseline

    Assessment by mRS

    Time frame: 1 month after each embolization

  7. Clinical outcome compared to baseline

    Assessment by mRS

    Time frame: 3-6 months after the final embolization

Secondary outcomes

  1. Adverse Events

    AE related to the PHIL procedure and/or to the techniques used during each embolization

    Time frame: 1 months after last 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

07

Study locations

16 sites
  • Rigshospitalet University
    Copenhagen, 2100, Denmark
  • CHU Pellgrin
    Bordeaux, 33000, France
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, 94270, France
  • CHU Limoges
    Limoges, 87000, France
  • La Fondation Rothschild
    Paris, 75010, France
  • Hôpital Pierre Paul Riquet
    Toulouse, 31059, France
  • Hospital Universitario General de Catalunya
    Barcelona, 08190, Spain
  • Hospital Nuestra Senora del Rosario
    Madrid, 28006, Spain
  • Hospital Universitario Virgen de la Arrixaca
    Murcia, 30120, Spain
  • Hospital Regional Universitario Carlos Haya
    Málaga, 29010, Spain
  • Hospital Universitario Virgen del Rocio
    Sevilla, 41013, Spain
  • Universitetssjukhus Umea
    Umeå, 90746, Sweden
  • Uppsala University
    Uppsala, 75185, Sweden
  • University Hospital Birmingham
    Birmingham, B15 2TH, United Kingdom
  • Western General Hospital
    Edinburgh, EH4 2XU, United Kingdom
  • Charing Cross Hospital
    London, W 8RF, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Oct 2020, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Nov 14, 2017
StartActual
Nov 14, 2017
Primary completionActual
Oct 14, 2020
CompletionActual
Oct 14, 2020
Last update
Jul 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03341039
Collaborators
ClinSearch
Responsible party
Sponsor
First posted
Nov 14, 2017
Start date
Nov 14, 2017
Primary completion
Oct 14, 2020
Completion
Oct 14, 2020
Last update
Jul 29, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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