RECRUITING

PHIL® Embolic System Pediatric IDE

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Conditions

Arterio-venous FistulaIntracranial Arteriovenous MalformationsPediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.

Official Title

Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population

Quick Facts

Study Start:2019-04-16
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03731000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is \<22 years of age
  2. * Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
  3. * Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure
  4. * Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.
  1. * Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
  2. * Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
  3. * Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
  4. * Female subject is currently pregnant.
  5. * Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease
  6. * Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
  7. * Evidence of active infection at the time of treatment.
  8. * Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
  9. * Subject weighs ≤ 2.5kg Angiographic
  10. * Subject has severe calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.
  11. * Contra-indication to DSA, CT scan or MRI/ MRA
  12. * History of intracranial vasospasm not responsive to medical therapy
  13. * Extra-cranial stenosis or parent vessel stenosis \> 50% proximal to the target lesion to be treated.
  14. * Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis

Contacts and Locations

Study Contact

Sukaina Davdani
CONTACT
(212) 241-2524
sukaina.davdani@mountsinai.org
Cynthia Nguyen
CONTACT
2065188505
cynthia.nguyen@mountsinai.org

Principal Investigator

Alejandro Berenstein, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Johanna Fifi, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Alejandro Berenstein

  • Alejandro Berenstein, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Johanna Fifi, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-16
Study Completion Date2027-12

Study Record Updates

Study Start Date2019-04-16
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Pediatric

Additional Relevant MeSH Terms

  • Arterio-venous Fistula
  • Intracranial Arteriovenous Malformations