Dural Arteriovenous FistulaNCT03317821
PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF
An observational study of Dural Arteriovenous Fistula, run by Microvention-Terumo, Inc. at 16 sites in 5 countries.
Trial summary
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dural Arteriovenous Fistula
- How many people
- 70 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 18 Sep 2017to 11 Mar 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients having an untreated dural arteriovenous fistula requiring treatment will be screened by the investigational sites. Those eligible to be treated with PHIL® will be enrolled after having dated and signed an informed consent form as per appropriate regulation in the participating country.
Who may be able to join
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
- Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
- Patient is at least 18 years of age.
Who cannot join
- Patient has multiple dAVFs to be treated.
- Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
- Patient does not give consent to the collection and processing of data required for centralized monitoring
- 3. Any condition that could prevent patient follow up.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
France5 sites
CHU Pellgrin
Bordeaux, 33000
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
CHU Limoges
Limoges, 87000
La Fondation Rothschild
Paris, 75010
Hôpital Pierre Paul Riquet
Toulouse, 31059
Spain5 sites
Hospital Universitario General de Catalunya
Barcelona, 08190
Hospital Nuestra Senora del Rosario
Madrid, 28006
Hospital Regional Universitario Carlos Haya
Málaga, 29010
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario Virgen del Rocio
Seville, 41013
United Kingdom3 sites
University Hospital Birmingham
Birmingham, B15 2TH
Western General Hospital
Edinburgh, EH4 2XU
Charing Cross Hospital
London, W6 8RF
Sweden2 sites
Universitetssjukhus Umea
Umeå, 90746
Uppsala University
Uppsala, 75185
About this study
Official title: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
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 dural ArterioVenous Fistula (dAVF). 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 an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.
The expected approximate study duration is 38 months.
- Conditions
- Dural Arteriovenous Fistula
- Medical subject headings
- Central Nervous System Vascular Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and assessment of neurological status at 1 month after each embolization
Neurological assessment by mRS
Measured: 1 month
Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
Cure rate assessment by Angiography
Measured: 3-6 months after last embolization
Secondary outcomes (2)
Number of adverse events and assessment of neurological status
Neurological assessment by mRS
Measured: 3-6 months after last embolization
Improvement in the quality of life of the patient and changes in patients symptoms
Assessed by Quality of Life Questionnaire EQ 5D
Measured: 3-6 months after last embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start18 Sep 2017
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317821
- Sponsor's protocol ID
- dAVF-Phil Registry
- Status last verified
- Jul 2021
- First submitted
- 18 Oct 2017
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
- ClinicalTrials.gov ID
- NCT03317821
- Acronym / sponsor ID
- dAVF-Phil Registry
- Conditions
- Dural Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
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 dural ArterioVenous Fistula (dAVF). 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 an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.
The expected approximate study duration is 38 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients having an untreated dural arteriovenous fistula requiring treatment will be screened by the investigational sites. Those eligible to be treated with PHIL® will be enrolled after having dated and signed an informed consent form as per appropriate regulation in the participating country.
Key inclusion criteria (3 listed)
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
- Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
- Patient is at least 18 years of age.
Key exclusion criteria (4 listed)
- Patient has multiple dAVFs to be treated.
- Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
- Patient does not give consent to the collection and processing of data required for centralized monitoring
- 3. Any condition that could prevent patient follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of adverse events and assessment of neurological status at 1 month after each embolization
Time frame: 1 month
Neurological assessment by mRS
Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
Time frame: 3-6 months after last embolization
Cure rate assessment by Angiography
2 secondary outcomes
Number of adverse events and assessment of neurological status
Time frame: 3-6 months after last embolization
Improvement in the quality of life of the patient and changes in patients symptoms
Time frame: 3-6 months after last embolization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dural Arteriovenous Fistula, run by Microvention-Terumo, Inc. at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Spain, United Kingdom, Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events and assessment of neurological status at 1 month after each embolization (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.