Clinical study of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System

UMIN ID: UMIN000008975

Registered date:26/09/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Wide-Necked Intracranial Artery Aneurysms
• Date of first enrollment: 2012/09/27
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System

Outcome(s)

• Primary Outcome: Clinical success:The all of the following criteria within 6 months. 1. Successful placement of the TCD-11114; 2. Parent artery patency; 3. Successful the TCD-11114 placement with satisfactory coil mass position; 4. Non occurrence of any major stroke or death within 30 days; 5. Non occurrence of major ipsi-lateral stroke or neurological death within 6months

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Terumo Corporation
• Source(s) of Monetary Support: Terumo Corporation