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



Status:Recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:21 - 70
Updated:12/15/2018
Start Date:September 1, 2015
End Date:December 31, 2023
Contact:Royce Yun
Email:ryun1@its.jnj.com
Phone:7143158962

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A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System When Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-necked Saccular Intracranial Aneurysms

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

The study is a prospective, multi-center, single arm, clinical study to evaluate the safety
and effectiveness of the ENTERPRISE stent when used in conjunction with endovascular coil
embolization in the treatment of unruptured wide-neck, intracranial, saccular anterior
circulation aneurysms (≤ 10 mm). The primary objectives of the study are to evaluate the rate
of complete angiographic occlusion at 12 months.

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
We found this trial at
11
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Philippe Gailloud, MD
Phone: 410-502-0736
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Edward Greenberg, MD
Phone: 703-269-4752
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Adam Polifka, MD
Phone: 352-273-9000
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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Allentown, Pennsylvania 18105
Principal Investigator: Darryn Shaff, MD
Phone: 610-402-9543
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Allentown, PA
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Buffalo, New York 14215
Principal Investigator: Kenneth Snyder, MD
Phone: 716-218-1000
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Buffalo, NY
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Ali Alaraj, MD
Phone: 312-996-4842
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: John Terry, MD
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, OH
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Englewood, Colorado 80112
Principal Investigator: Donald Frei, MD
Phone: 720-493-3403
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Englewood, CO
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Jacksonville, Florida 32207
Principal Investigator: Ricardo Hanel, MD
Phone: 904-388-6518
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Jacksonville, FL
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New York, New York 10029
Principal Investigator: Reade DeLeacy, MD
Phone: 212-241-6369
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New York, NY
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Worcester, Massachusetts 01655
Principal Investigator: Francesco Massari, MD
Phone: 508-334-8329
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Worcester, MA
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