Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: September 01, 2015
End Date: November 01, 2018
Inclusion Criteria:
- Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm
- Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment
- Subject is willing to comply with specified follow-up evaluation
Exclusion Criteria:
- Planned staged procedure
- Currently enrolled in another investigational device or drug study
- Target aneurysm that has been previously treated
- Mycotic, fusiform or dissecting aneurysm
- Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0
- A serum creatinine level > 2.5 mg/dL within 7 days prior to index procedure
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Conditions:
- Aneurysm
- Intracranial Aneurysm