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

Stopped early · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.

Key facts

Study ID

NCT02532517

Run by

Cerenovus, Part of DePuy Synthes Products, Inc.

People needed

45

Starts

2015-09-01

Expected to finish

2019-09-21

Last updated by the study team

2020-10-23

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Radiology Imaging Associates — Englewood, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Lyerly Neurosurgery, an Affiliate of Baptist Health — Jacksonville, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• University of Buffalo — Buffalo, New York, United States
• Mount Sinai Health System — New York, New York, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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