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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03341039
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
ClinSearch
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

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.


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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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021





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 ]


Information from the National Library of Medicine

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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

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): NCT03341039


Locations
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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

Additional Information:

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT03341039     History of Changes
Other Study ID Numbers: cAVM-PHIL Registry
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
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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Vascular Malformations
Central Nervous System Vascular Malformations
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Intracranial Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nervous System Malformations
Intracranial Arterial Diseases