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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intracranial Bifurcating Aneurysms

Intervention / Treatment
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* Device: BARREL VRD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 and 85 years old. A wide-neck de novo or non-de novo aneurysm. Appropriate informed consent obtainable as determined by local IRB. Life expectancy > 24 months. Exclusion Criteria: Aneurysm rupture within 30 days of enrollment. Bifurcating aneurysms not treatable with coiling. Subject has platelet count of <70,000. Subject has known allergies to nickel-titanium metal. Subject has known allergies to aspirin or heparin. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated). Subject is currently participating in another clinical research study. Subject is pregnant or breastfeeding. Subject has participated in a drug study within the last 30 days. Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: BARREL VRD<br>The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. | Device: BARREL VRD<br>* The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. | The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for > 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale | 12 months, after device implant | 
| Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture | The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows: Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac | 12 months, after device implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successfully Deployed Barrel VRD | This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD. | Index Procedure, Day 0 | 
| Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months | This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success. Raymond Grade Scale Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac. | 12 months, after device implant | 
| Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline | This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline. The Modified Rankin Score is a scale for measuring general functionality as follows: 0: No symptoms at all No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead | 12 months, after device implant | 
| Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: <25%, 25-50%, 51-75%, >75%. | At 12 Months +/- 8 weeks | 
| Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks | This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device. | 30 Days and 12 months +/- 8 weeks |