The Reverse Barrel™ VRD Intracranial Aneurysm Trial (Barrel)

Multi-center Non-randomized Clinical Investigation of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide Neck Intracranial Bifurcation and Branch Aneurysms

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: Barrel™ Vascular Reconstruction Device (VRD)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intracranial Aneurysm Treatment; 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.

Device: Barrel™ Vascular Reconstruction Device (VRD); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful aneurysm occlusion with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure	Effectiveness measures are successful aneurysm treatment with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure in the absence of retreatment, parent artery stenosis (> 50%), or target aneurysm rupture. Safety measures are the absence of neurological death or major stroke at 12 months post treatment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful delivery of the device measured by technical success.	Technical success is defined as access to the lesion, successful deployment of the Barrel™ VRD and correct positioning of the device over the aneurysm.	At implant up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	Functional outcome as defined by modified Rankin Scale (mRS) at 12 months.	At 12 months

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Principal Investigator: Michel Piotin, M.D., Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

Publications and helpful links

General Publications

• Gory B, Blanc R, Turjman F, Berge J, Piotin M. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study. J Neurointerv Surg. 2018 Oct;10(10):969-974. doi: 10.1136/neurintsurg-2017-013602. Epub 2018 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 12, 2015
• Study Completion (Actual): December 12, 2015

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Endovascular Therapy; Intracranial Aneurysm Treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: Barrel OUS VRD-001