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

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 85
Updated:	12/27/2018
Start Date:	October 13, 2014
End Date:	July 21, 2017

Prospective, Multi-Center, Single-Arm Study of Reverse Medical Barrel™ Vascular Reconstruction Device for Adjunctive Treatment to Embolic Coils in Wide-Neck, Intracranial, Bifurcating Aneurysms of Middle Cerebral and Basilar Arteries

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.

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.

We found this trial at

sites

Baptist Hospital of Miami, BCVI

Miami, Florida 33176

Principal Investigator: Italo Linfante, MD

Phone: 786-596-4882

from

Miami, FL