Study of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide-Neck, Intracranial, Bifurcating/ Branching Aneurysms
This trial is active, not recruiting.
|Condition||intracranial bifurcating aneurysms|
|Sponsor||Medtronic Neurovascular Clinical Affairs|
|Start date||June 2014|
|End date||January 2018|
|Trial size||138 participants|
|Trial identifier||NCT02179190, VRD-001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Jacksonville, FL||Baptist Medical Center Jacksonville||no longer recruiting|
|Miami, FL||Baptist Hospital of Miami, BCVI||no longer recruiting|
|Tallahassee, FL||Tallahassee Neurological Clinic||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Primary Safety Endpoint
time frame: 12 months
Primary Efficacy Endpoint
time frame: 12 months
Male or female participants from 18 years up to 85 years old.
- 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.
- 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.
|Official title||Prospective, Multi-Center, Single-Arm Study of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide-Neck, Intracranial, Bifurcating/ Branching Aneurysms of Middle Cerebral and Basilar Arteries|
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