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PHIL in the Treatment of Intracranial dAVF. (PHIL dAVF)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467542
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Brief Summary:
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.

Condition or disease Intervention/treatment Phase
Arteriovenous Dural Fistula Device: PHIL® Liquid Embolic System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: dAVF treatment
PHIL® Liquid Embolic System
Device: PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)




Primary Outcome Measures :
  1. Subjects with neurological death or ipsilateral stroke [ Time Frame: 30 days ]
    Reported incidences of death or ipsilateral stroke


Secondary Outcome Measures :
  1. Technical events during the PHIL embolization procedure(s) [ Time Frame: During the procedure ]
    Reported incidences of technical events with PHIL device

  2. Device-related adverse events [ Time Frame: 3-6 month follow-up ]


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:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 22 - 80 years.
  • Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
  • Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
  • Subject has an intracranial dAVF

Exclusion Criteria:

  • Subject having multiple dAVFs to be treated.
  • Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
  • Subject has known allergies to dimethylsulfoxide, iodine.
  • Subject is currently participating in another clinical study
  • Female subject is currently pregnant.
  • Subject has co-morbid conditions that may limit survival to less than 24 months.

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): NCT03467542


Contacts
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Contact: Jennifer Jelf 714.247.8187 jennifer.jelf@microvention.com

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Principal Investigator: John Dalfino, MD         
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: J Mocco, MD Mt. Sinai
Principal Investigator: Alan Boulos, MD Albany Medical College
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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT03467542    
Other Study ID Numbers: CL11005
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Microvention-Terumo, Inc.:
Fistula
Intracranial
Dural
Arteriovenous
Liquid Embolic
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical