i-CURE CSDH

This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.

This is a prospective, multi-center, single arm, post-market study designed to evaluate the clinical performance and safety of i-ED COILs when used for endovascular embolization of the MMA in the treatment of patients with subacute or chronic SDH.

In order to participate you must meet the following inclusion criteria:

• Are male or female and at least 18 years of age at the time of consent.
• Have a pre-morbid mRS of 0 to 3.
• Have SDH that is symptomatic, requiring intervention and presenting with one or more of the following neurological symptoms:
  • Headache
  • Cognitive decline
  • Speech difficulty or aphasia
  • Gait impairment or imbalance
  • Focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop)
  • Seizure
• Have SDH that exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift.
• Have subacute or chronic SDH. The quantity of acute blood must be ≤50%.
• Have a Markwalder score in the range of 0-2.
• Subject, or his/her legally authorized representative (LAR), understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent Form.
• Female Subjects of child-bearing potential must provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial.
• Are willing and able to return for follow-up visits, as required per protocol.

You will be excluded from the study if any of the following exclusion criteria apply to you:

• Are presenting with an acute need for emergent subdural hematoma evacuation.
• Have SDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement).
• Have SDH that developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy.
• Have an intracranial mass other than subdural hematoma.
• Have pre-planned use of coils along with another adjunctive device (e.g. liquid embolic, particles, etc).
• Have a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
• Have significant liver function impairment, renal failure or patients on dialysis.
• Are a Female Subject who is pregnant and/or breastfeeding
• Are participating in another clinical study of which the primary endpoint has not been achieved.
• Have significant tortuosity or anatomical factors making angiography difficult.
• Have evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 180-day follow-up period.
• Have bilateral subacute or chronic SDH requiring targeted treatment of both sides.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.