Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
NCT ID: NCT02532517
Last Updated: 2020-10-23
Study Results
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View full resultsBasic Information
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TERMINATED
NA
45 participants
INTERVENTIONAL
2015-09-01
2019-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enterprise
CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
Interventions
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CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
No
Sponsors
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Cerenovus, Part of DePuy Synthes Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Frei, MD
Role: PRINCIPAL_INVESTIGATOR
Radiology Imaging Associates
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NV-IDE-1001
Identifier Type: -
Identifier Source: org_study_id
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