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

Medtronic

Status: Completed

Conditions: Intracranial Bifurcating Aneurysms

Treatments: Device: BARREL VRD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179190

VRD-001

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

BARREL VRD

Experimental group

Description:

The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.

Treatment:

Device: BARREL VRD