Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms

Completed · Not applicable

Conditions studied: Intracranial Bifurcating Aneurysms

In brief

Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.

Key facts

Study ID: NCT02179190
Run by: Medtronic Neurovascular Clinical Affairs
People needed: 138
Starts: 2014-10-13
Expected to finish: 2017-07-21
Last updated by the study team: 2018-12-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female between 18 and 85 years old.
A wide-neck de novo or non-de novo aneurysm.
Appropriate informed consent obtainable as determined by local IRB.
Life expectancy > 24 months.

You may not qualify if…

Aneurysm rupture within 30 days of enrollment.
Bifurcating aneurysms not treatable with coiling.
Subject has platelet count of <70,000.
Subject has known allergies to nickel-titanium metal.
Subject has known allergies to aspirin or heparin.
Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
Subject is currently participating in another clinical research study.
Subject is pregnant or breastfeeding.
Subject has participated in a drug study within the last 30 days.
Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.

Where it is running

Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
Baptist Hospital of Miami, BCVI — Miami, Florida, United States
Tallahassee Neurological Clinic — Tallahassee, Florida, United States

Full record on ClinicalTrials.gov

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