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Lead
Kaneka Medical America LLC
Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)
Study Duration
Anticipated timeline for study:
Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Target aneurysm of 4mm - 14mm in size
Ruptured or unruptured
Suitable for embolization with coils
May be treated with or without assist devices
You may not be if
Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
Pre-planned staged procedure of target aneurysm
mRS score 3 or more
Hunt Hess Score more than 3 for subjects with ruptured aneurysm
Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)
Clareo Health | Kaneka Endovascular Embolization and Protection
