Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2019-04-16
2027-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PHIL® device
Using device
PHIL® device
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas
Interventions
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PHIL® device
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas
Eligibility Criteria
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Inclusion Criteria
* Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
* Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure
* 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.
Exclusion Criteria
* Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
* Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
* Female subject is currently pregnant.
* 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
* Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
* Evidence of active infection at the time of treatment.
* Subject has a history of bleeding diathesis or coagulopathy, international normalized 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 safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.
* 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 lesion to be treated.
* Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis
21 Years
ALL
No
Sponsors
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Alejandro Berenstein
OTHER
Responsible Party
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Alejandro Berenstein
Professor
Principal Investigators
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Alejandro Berenstein, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Tomoyoshi Shigematsu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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GCO 18-1298
Identifier Type: -
Identifier Source: org_study_id
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