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

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Bifurcating Aneurysms
• Intervention / Treatment: Device: BARREL VRD

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center Jacksonville
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami, BCVI
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female between 18 and 85 years old.
2. A wide-neck de novo or non-de novo aneurysm.
3. Appropriate informed consent obtainable as determined by local IRB.
4. Life expectancy > 24 months.

Exclusion Criteria:

1. Aneurysm rupture within 30 days of enrollment.
2. Bifurcating aneurysms not treatable with coiling.
3. Subject has platelet count of <70,000.
4. Subject has known allergies to nickel-titanium metal.
5. Subject has known allergies to aspirin or heparin.
6. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
7. Subject is currently participating in another clinical research study.
8. Subject is pregnant or breastfeeding.
9. Subject has participated in a drug study within the last 30 days.
10. Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.

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: BARREL VRD; 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; The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reported Device Related Serious Adverse Events	This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events	From the point of consent until participant exits the study at 1 year

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Principal Investigator: J Mocco, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2014
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): July 21, 2017

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): July 1, 2014

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: VRD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes