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 |
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.
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.
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
Jacksonville, Florida 32207
Principal Investigator: Ricardo Hanel, MD
Phone: 904-388-6518
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3400 N Charles St
Baltimore, Maryland 21205
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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3300 Gallows Road
Falls Church, Virginia 22042
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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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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Allentown, Pennsylvania 18105
Principal Investigator: Darryn Shaff, MD
Phone: 610-402-9543
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Buffalo, New York 14215
Principal Investigator: Kenneth Snyder, MD
Phone: 716-218-1000
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2035 W Taylor St
Chicago, Illinois
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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1 Wyoming St,
Dayton, Ohio 45409
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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Englewood, Colorado 80112
Principal Investigator: Donald Frei, MD
Phone: 720-493-3403
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New York, New York 10029
Principal Investigator: Reade DeLeacy, MD
Phone: 212-241-6369
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Worcester, Massachusetts 01655
Principal Investigator: Francesco Massari, MD
Phone: 508-334-8329
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