PHIL® Embolic System Pediatric IDE

Last updated: November 1, 2024
Sponsor: Alejandro Berenstein
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abnormal Blood Vessels (Arteriovenous Malformations)

Treatment

PHIL® device

Clinical Study ID

NCT03731000
GCO 18-1298
  • Ages < 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is <22 years of age

  • Subject and legally authorized representative are willing and capable of complyingwith all study protocol requirements, including specified follow-up period.

  • Subject's legally authorized representative(s) must sign and date an IRB approvedwritten informed consent prior to initiation of any study procedure

  • Subject has an intracranial dAVF that is deemed appropriate for embolization withPHIL without significantly increased risk to collateral or adjacent territories, ORsubject has been previously treated with other embolic materials for dAVF.

Exclusion

Exclusion Criteria:

  • Subject presents with an intracranial mass or is currently undergoing radiationtherapy for carcinoma or sarcoma of the head or neck region

  • Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.

  • Subject with a history of life threatening allergy to contrast media (unlesstreatment for allergy is tolerated).

  • Female subject is currently pregnant.

  • Subject has an acute or chronic life-threatening illness other than the neurologicaldisease to be treated in this study including but not limited to any malignancy ordebilitating autoimmune disease

  • Subject has existing severe or advanced comorbid conditions which significantlyincrease general anesthesia and/ or surgical risk

  • Evidence of active infection at the time of treatment.

  • Subject has a history of bleeding diathesis or coagulopathy, internationalnormalized ratio (INR) greater than 1.5, or will refuse blood transfusions.

  • Subject weighs ≤ 2.5kg Angiographic

  • Subject has severe calcification or vascular tortuosity that may preclude the safeintroduction of the sheath, guiding catheter, or access to the lesion with themicrocatheter.

  • Contra-indication to DSA, CT scan or MRI/ MRA

  • History of intracranial vasospasm not responsive to medical therapy

  • Extra-cranial stenosis or parent vessel stenosis > 50% proximal to the target lesionto be treated.

  • Subject has a propensity to contrast induced renal injury or a potential tonephrogenic systemic fibrosis

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: PHIL® device
Phase:
Study Start date:
April 16, 2019
Estimated Completion Date:
December 31, 2027

Study Description

Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.

Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.

Connect with a study center

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

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