The Reverse Barrel™ VRD Intracranial Aneurysm Trial

Medtronic

Status: Completed

Conditions: Intracranial Aneurysms

Treatments: Device: Barrel™ Vascular Reconstruction Device (VRD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125097

Barrel OUS VRD-001

Details and patient eligibility

About

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Summary Inclusion Criteria:

1. Male or female ≥18 years old.

2. A wide neck, intracranial, bifurcating or branch aneurysm with a neck ≥4 mm or a dome-to-neck ratio <2, including non-de novo aneurysms where no stent was utilized.

3. Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).

4. Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.

5. Subject is eligible to undergo a procedure with the use of contrast media.

6. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.

7. Subject has given written informed consent.

8. Life expectancy > 12 months.

Summary Exclusion Criteria:

1. Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.

2. Subject is currently undergoing radiation therapy.

3. Subject has known allergies to nickel-titanium metal.

4. Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.

5. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).

6. Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).

7. Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.

8. Subject is currently participating in another clinical research study.

9. Subject has had a previous intracranial stenting procedure associated with the target aneurysm.

10. Subject is unable to complete the required follow-up.

11. Subject is pregnant or breastfeeding.(Females of childbearing potential must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)

12. Subject has participated in a drug study within the last 30 days.

13. Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.

14. Extradural aneurysms.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intracranial Aneurysm Treatment

Experimental group

Description:

Barrel™ Vascular Reconstruction Device (VRD) is Intended for use with embolic coils for the treatment of wide-neck bifurcating or branch intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm, measured by 2D Digital Subtraction Angiography (DSA). Wide-neck is defined as having a neck width ≥ 4 mm or a dome-to-neck ratio \< 2.

Treatment:

Device: Barrel™ Vascular Reconstruction Device (VRD)