Skip to main content
OpenTrials
Completed

NCT Number: NCT02179190

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intracranial Bifurcating Aneurysms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Medical Center Jacksonville, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BARREL VRD

Device

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 outcomes

  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 outcomes

  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

    • 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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2014
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.