This trial is active, not recruiting.

Condition intracranial bifurcating aneurysms
Treatment barrel vrd
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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
barrel vrd
BARREL VRD placement adjunctive to coiling treatment.

Primary Outcomes

Primary Safety Endpoint
time frame: 12 months
Primary Efficacy Endpoint
time frame: 12 months

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs.