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

Primary Purpose

Intracranial Bifurcating Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BARREL VRD
Sponsored by
Medtronic Neurovascular Clinical Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Bifurcating Aneurysms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baptist Medical Center Jacksonville
  • Baptist Hospital of Miami, BCVI
  • Tallahassee Neurological Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BARREL VRD

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Number of Participants With Successfully Deployed Barrel VRD
This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.
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.
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
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%.
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.

Full Information

First Posted
June 27, 2014
Last Updated
December 4, 2018
Sponsor
Medtronic Neurovascular Clinical Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT02179190
Brief Title
Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
July 21, 2017 (Actual)
Study Completion Date
July 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BARREL VRD
Arm Type
Experimental
Arm Description
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Intervention Type
Device
Intervention Name(s)
BARREL VRD
Intervention Description
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Primary Outcome Measure Information:
Title
Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
Description
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
Time Frame
12 months, after device implant
Title
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
Description
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
Time Frame
12 months, after device implant
Secondary Outcome Measure Information:
Title
Number of Participants With Successfully Deployed Barrel VRD
Description
This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.
Time Frame
Index Procedure, Day 0
Title
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
Description
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.
Time Frame
12 months, after device implant
Title
Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline
Description
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
Time Frame
12 months, after device implant
Title
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%
Description
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%.
Time Frame
At 12 Months +/- 8 weeks
Title
Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks
Description
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.
Time Frame
30 Days and 12 months +/- 8 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Reported Device Related Serious Adverse Events
Description
This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events
Time Frame
From the point of consent until participant exits the study at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Mocco, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist Hospital of Miami, BCVI
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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