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The Reverse Barrel™ VRD Intracranial Aneurysm Trial (Barrel)

Primary Purpose

Intracranial Aneurysms

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Barrel™ Vascular Reconstruction Device (VRD)

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring Intracranial Aneurysm Treatment, Endovascular Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Summary Inclusion Criteria:

Male or female ≥18 years old.
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.
Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).
Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.
Subject is eligible to undergo a procedure with the use of contrast media.
Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
Subject has given written informed consent.
Life expectancy > 12 months.
-

Summary Exclusion Criteria:

Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.
Subject is currently undergoing radiation therapy.
Subject has known allergies to nickel-titanium metal.
Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.
Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).
Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
Subject is currently participating in another clinical research study.
Subject has had a previous intracranial stenting procedure associated with the target aneurysm.
Subject is unable to complete the required follow-up.
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.)
Subject has participated in a drug study within the last 30 days.
Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.
Extradural aneurysms.
-

Sites / Locations

Fondation Ophtalmologique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intracranial Aneurysm Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02125097

First Posted

April 22, 2014

Last Updated

January 10, 2019

Sponsor

Medtronic Neurovascular Clinical Affairs

1. Study Identification

Unique Protocol Identification Number

NCT02125097

Brief Title

The Reverse Barrel™ VRD Intracranial Aneurysm Trial

Acronym

Barrel

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2013 (Actual)

Primary Completion Date

December 12, 2015 (Actual)

Study Completion Date

December 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Neurovascular Clinical Affairs

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysms

Keywords

Intracranial Aneurysm Treatment, Endovascular Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intracranial Aneurysm Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Barrel™ Vascular Reconstruction Device (VRD)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Successful delivery of the device measured by technical success.

Description

Technical success is defined as access to the lesion, successful deployment of the Barrel™ VRD and correct positioning of the device over the aneurysm.

Time Frame

At implant up to 30 days

Other Pre-specified Outcome Measures:

Title

Functional outcome

Description

Functional outcome as defined by modified Rankin Scale (mRS) at 12 months.

Time Frame

At 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Summary Inclusion Criteria: Male or female ≥18 years old. 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. Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA). Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center. Subject is eligible to undergo a procedure with the use of contrast media. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up. Subject has given written informed consent. Life expectancy > 12 months. - Summary Exclusion Criteria: Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening. Subject is currently undergoing radiation therapy. Subject has known allergies to nickel-titanium metal. Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated). Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB). Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke. Subject is currently participating in another clinical research study. Subject has had a previous intracranial stenting procedure associated with the target aneurysm. Subject is unable to complete the required follow-up. 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.) Subject has participated in a drug study within the last 30 days. Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure. Extradural aneurysms. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel Piotin, M.D.

Organizational Affiliation

Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondation Ophtalmologique Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

29437935

Citation

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.

Results Reference

derived

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The Reverse Barrel™ VRD Intracranial Aneurysm Trial

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