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.
Inclusion Criteria: 1. Male or female between 18 and 85 years old. 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: 1. Aneurysm rupture within 30 days of enrollment. 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.
|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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