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

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ClinicalTrials.gov Identifier: NCT02179190
Recruitment Status : Completed
First Posted : July 1, 2014
Results First Posted : December 5, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

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.

Condition or disease Intervention/treatment Phase
Intracranial Bifurcating Aneurysms Device: BARREL VRD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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.




Primary Outcome Measures :
  1. Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. [ Time Frame: 12 months, after device implant ]

    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


  2. 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 [ Time Frame: 12 months, after device implant ]

    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 :
  1. Number of Participants With Successfully Deployed Barrel VRD [ Time Frame: Index Procedure, Day 0 ]
    This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.

  2. 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 [ Time Frame: 12 months, after device implant ]

    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.


  3. Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline [ Time Frame: 12 months, after device implant ]

    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

    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. Moderate disability; requiring some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. Dead

  4. 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% [ Time Frame: At 12 Months +/- 8 weeks ]
    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%.

  5. Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks [ Time Frame: 30 Days and 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.


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179190


Locations
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United States, Florida
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207
Baptist Hospital of Miami, BCVI
Miami, Florida, United States, 33176
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: J Mocco, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Medtronic Neurovascular Clinical Affairs:

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02179190     History of Changes
Other Study ID Numbers: VRD-001
First Posted: July 1, 2014    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases