The Reverse Barrel™ VRD Intracranial Aneurysm Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intracranial Aneurysms

Intervention / Treatment
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* Device: Barrel™ Vascular Reconstruction Device (VRD)


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracranial Aneurysm Treatment<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Aneurysm Treatment, Endovascular Therapy