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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467542
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date February 10, 2022
Actual Study Start Date  ICMJE August 24, 2018
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)		 Subjects with neurological death or ipsilateral stroke [ Time Frame: 30 days ]
Reported incidences of death or ipsilateral stroke
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • Technical events during the PHIL embolization procedure(s) [ Time Frame: During the procedure ]
    Reported incidences of technical events with PHIL device
  • Device-related adverse events [ Time Frame: 3-6 month follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PHIL in the Treatment of Intracranial dAVF.
Official Title  ICMJE PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arteriovenous Dural Fistula
Intervention  ICMJE Device: PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Study Arms  ICMJE Experimental: dAVF treatment
PHIL® Liquid Embolic System
Intervention: Device: PHIL® Liquid Embolic System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2022)		 75
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)		 45
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03467542
Other Study ID Numbers  ICMJE CL11005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Microvention-Terumo, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Microvention-Terumo, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J Mocco, MD Mt. Sinai
Principal Investigator: Alan Boulos, MD Albany Medical College
PRS Account Microvention-Terumo, Inc.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP