Clinical study of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System
- Conditions
- Wide-Necked Intracranial Artery Aneurysms
- Registration Number
- JPRN-UMIN000008975
- Lead Sponsor
- Terumo Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
Exclusion Criteria; (1)Subject with Subarachnoid hemorrhage (SAH, ruptured cerebral aneurysm). (2)Subject who has an intracranial mass, abscess, or other agglomeration from an infection.Subject who is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region. (3)Subject with dementia. (4) Subject with a history of bleeding diathesis, blood clotting defect, or with International Normalized Ratio (INR) >= 1.5, and or who refuses blood transfusion. (5) Subject with serum creatinine level > 2.0 mg/dL. (6)Subject with a life threatening allergy to contrast. (7)Subject with known allergies to nickel-titanium metal. (8) Subject with known allergies to aspirin, heparin, ticlopidine. (9)Subject who is expected to lives less than 6 months. (10)Subject who is currently participating in another clinical research study for medical devices and/or medicine. (11) Subject who placed a carotid stent for symptomatic hemodynamic derangement within 12 weeks. (12)Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation). (13)Subject who is in pregnancy or is suspected pregnancy. (14)Subject who has allergies or tolerance to aspirin and/or ticlopidine at preoperative antiplatelet therapy. Angiographic Exclusion Criteria; (15)Subject with a maximum diameter < 5 mm of aneurysm. (16)Subject with aneurysm arises from a parent vessel with a diameter of < 2.0 mm and > 4.5 mm. (17)Subject who judged that the target aneurysm is unsuitable for vascular treatment by angiography. (18)Subject has an arteriovenous malformation (AVM) in the territory of the target aneurysm. (19)Subject's aneurysm is expected to require more than one stent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method