Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
NCT ID: NCT02179190
Last Updated: 2018-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2014-10-13
2017-07-21
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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BARREL VRD
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
BARREL VRD
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Interventions
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BARREL VRD
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Eligibility Criteria
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Inclusion Criteria
2. A wide-neck de novo or non-de novo aneurysm.
3. Appropriate informed consent obtainable as determined by local IRB.
4. Life expectancy \> 24 months.
Exclusion Criteria
2. Bifurcating aneurysms not treatable with coiling.
3. Subject has platelet count of \<70,000.
4. Subject has known allergies to nickel-titanium metal.
5. Subject has known allergies to aspirin or heparin.
6. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
7. Subject is currently participating in another clinical research study.
8. Subject is pregnant or breastfeeding.
9. Subject has participated in a drug study within the last 30 days.
10. Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.
18 Years
85 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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J Mocco, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Baptist Hospital of Miami, BCVI
Miami, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VRD-001
Identifier Type: -
Identifier Source: org_study_id