Phase
Condition
Abnormal Blood Vessels (Arteriovenous Malformations)
Treatment
PHIL® device
Clinical Study ID
Ages < 21 All Genders
Study Summary
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
Study Description
Connect with a study center
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
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