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PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

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ClinicalTrials.gov Identifier: NCT03317821
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
ClinSearch
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Brief 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.

Condition or disease
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 60 patients will be enrolled in this study in 16 European Institutions.

The expected approximate study duration is 24 months.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas




Primary Outcome Measures :
  1. Number of adverse events and assessment of neurological status at 1 month after each embolization [ Time Frame: 1 month ]
    Neurological assessment by mRS

  2. 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


Secondary Outcome Measures :
  1. Number of adverse events and assessment of neurological status [ Time Frame: 3-6 months after last embolization ]
    Neurological assessment by mRS

  2. Improvement in the quality of life of the patient and changes in patients symptoms [ Time Frame: 3-6 months after last embolization ]
    Assessed by Quality of Life Questionnaire EQ 5D



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
  2. 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).
  3. Patient is at least 18 years of age.

Exclusion Criteria:

  1. Patient has multiple dAVFs to be treated.
  2. 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.
  3. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317821


Contacts
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Contact: Habib NACER-CHERIF +33 (0) 6 81 97 46 24 habib.nacercherif@microvention.com
Contact: Patricia Boyer +33 (0)6 70 13 94 98 patricia.boyer@microvention.com

Locations
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Denmark
Rigshospitalet University Not yet recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Markus Holtmannspötter, MD         
France
CHU Pellgrin Recruiting
Bordeaux, France, 33000
Contact: Florent Maire       florent.maire@chu-bordeaux.fr   
Principal Investigator: Xavier Barreau, MD         
Hôpital Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Principal Investigator: Laurent Spelle, MD         
CHU Limoges Recruiting
Limoges, France, 87000
Contact: Delphine Tarnaud       neuro-radiologie@chu-limoges.fr   
Principal Investigator: Charbel Mounayer         
La Fondation Rothschild Recruiting
Paris, France, 75010
Contact: Lopes Lucia       llopes@for.paris   
Principal Investigator: Michel Piotin, MD         
Hôpital Pierre Paul Riquet Recruiting
Toulouse, France, 31059
Principal Investigator: Anne-Christine Januel, MD         
Spain
Hospital Universitario General de Catalunya Recruiting
Barcelona, Spain, 08190
Principal Investigator: Leopoldo Guimaraens, MD         
Hospital Nuestra Senora del Rosario Recruiting
Madrid, Spain, 28006
Principal Investigator: Alfredo Casasco, MD         
Hospital Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain, 30120
Principal Investigator: Mariano Espinosa, MD         
Hospital Regional Universitario Carlos Haya Not yet recruiting
Málaga, Spain, 29010
Principal Investigator: Antonio Romance Garcia, MD         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Principal Investigator: Alejandro Gonzales Garcia, MD         
Sweden
Universitetssjukhus Umea Recruiting
Umeå, Sweden, 90746
Principal Investigator: Mats Cronqvist, MD         
Uppsala University Recruiting
Uppsala, Sweden, 75185
Principal Investigator: Ljbubisa Borota, MD         
United Kingdom
University Hospital Birmingham Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Saleh Lamin, MSc         
Western General Hospital Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Principal Investigator: Peter Mark Keston, MSc         
Charing Cross Hospital Not yet recruiting
London, United Kingdom, W6 8RF
Contact: Lesley Honeyfield       lesley.honeyfield@nhs.net   
Principal Investigator: Lyriakos Lobotesisi, MSc         
Sponsors and Collaborators
Microvention-Terumo, Inc.
ClinSearch

Additional Information:

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT03317821     History of Changes
Other Study ID Numbers: dAVF-Phil Registry
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Central Nervous System Vascular Malformations
Vascular Malformations
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Nervous System Malformations
Nervous System Diseases