Cerebral AV MalformationNCT03341039
PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)
An observational study of Cerebral AV Malformation, run by Microvention-Terumo, Inc. at 16 sites in 5 countries.
Trial 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 more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Cerebral AV Malformation
- How many people
- 20 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 14 Nov 2017to 14 Oct 2020
- How long will I take part?
- 15 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 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus.
Who may be able to join
- 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).
- 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.**
- All patients with a remaining cAVM, ruptured or unruptured, that has previously been treated with NS and/or RT may be included.
- 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).
Who cannot join
- cAVM not eligible for endovascular treatment
- cAVM previously treated with a non-adhesive liquid embolic agent other than PHIL®
- Treatment requiring the use of any other non-adhesive embolic liquid
- Patient is allergic to iodine
- Premature and newborn infant
- Patient with renal failure or significant liver impairment
Show all 9Show fewer
- Patient is participating in another study evaluating other medical devices, other procedures or medications.
- Any other condition that might prevent patient participation in the study or follow up
- Patient does not want to and/or refuses to give consent to the collection and processing of data required for centralized monitoring
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, W 8RF
Sweden2 sites
Universitetssjukhus Umea
Umeå, 90746
Uppsala University
Uppsala, 75185
About this study
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
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.
- Conditions
- Cerebral AV Malformation
- Medical subject headings
- Intracranial Arteriovenous Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cure rate
Measured: immediately after final embolization
Cure rate with regard to the aim of the endovascular treatment
Measured: immediately after final embolization
Overall cure rate
Measured: 3-6 months
Cure rate with regard to the aim of the endovascular treatment
Measured: 3-6 months
Clinical outcome compared to baseline
Assessment by mRS
Measured: up to 3 days
Clinical outcome compared to baseline
Assessment by mRS
Measured: 1 month after each embolization
Clinical outcome compared to baseline
Assessment by mRS
Measured: 3-6 months after the final embolization
Secondary outcomes (7)
Adverse Events
AE related to the PHIL procedure and/or to the techniques used during each embolization
Measured: 1 months after last embolization
Total volume of injected PHIL
Measured: during each embolization
Volume/superselective injection
Measured: during each embolization
Length of reflux of PHIL
Measured: during each embolization
Amount of pedicles catheterized
Measured: during each embolization
Overall injection time
Measured: during each embolization
Overall radiation dose given to the patient during EVT
Measured: during each embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start14 Nov 2017
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Why it stopped: Termination of the study due to low enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AV MalformationStudies 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
- 20 participants (actual)
- Target duration
- 15 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
- NCT03341039
- Sponsor's protocol ID
- cAVM-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 Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study
- ClinicalTrials.gov ID
- NCT03341039
- Acronym / sponsor ID
- cAVM-PHIL Registry
- Conditions
- Cerebral AV Malformation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination of the study due to low enrolment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 14 Nov 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus.
Key inclusion criteria (4 listed)
- 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).
- 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.**
- All patients with a remaining cAVM, ruptured or unruptured, that has previously been treated with NS and/or RT may be included.
- 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).
Key exclusion criteria (9 listed)
- cAVM not eligible for endovascular treatment
- cAVM previously treated with a non-adhesive liquid embolic agent other than PHIL®
- Treatment requiring the use of any other non-adhesive embolic liquid
- Patient is allergic to iodine
- Premature and newborn infant
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
Overall cure rate
Time frame: immediately after final embolization
Cure rate with regard to the aim of the endovascular treatment
Time frame: immediately after final embolization
Overall cure rate
Time frame: 3-6 months
Cure rate with regard to the aim of the endovascular treatment
Time frame: 3-6 months
Clinical outcome compared to baseline
Time frame: up to 3 days
Assessment by mRS
Clinical outcome compared to baseline
Time frame: 1 month after each embolization
Assessment by mRS
Clinical outcome compared to baseline
Time frame: 3-6 months after the final embolization
Assessment by mRS
7 secondary outcomes
Adverse Events
Time frame: 1 months after last embolization
Total volume of injected PHIL
Time frame: during each embolization
Volume/superselective injection
Time frame: during each embolization
Length of reflux of PHIL
Time frame: during each embolization
Amount of pedicles catheterized
Time frame: during each embolization
Overall injection time
Time frame: during each embolization
Overall radiation dose given to the patient during EVT
Time frame: during each embolization
Results and safety
The study was stopped early (reason given: Termination of the study due to low enrolment). Results are not available in the source record.
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 Cerebral AV Malformation, 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 4 inclusion and 9 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: stopped early, 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 was stopped early (reason given: Termination of the study due to low enrolment). Results are not available in the source record.
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?
Overall cure rate (time frame: immediately after final embolization). The study lists 7 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.