Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device

ID#: NCT02532517

Age: 21 - 70 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: September 01, 2015

End Date: November 01, 2018

Contact Information:
Royce Yun
Summary: The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.

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