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Completed

NCT Number: NCT02125097

The Reverse Barrel™ VRD Intracranial Aneurysm Trial

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.

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Key information

Conditions

Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

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

Summary Inclusion Criteria:

  • Male or female ≥18 years old.
  • A wide neck, intracranial, bifurcating or branch aneurysm with a neck ≥4 mm or a dome-to-neck ratio <2, including non-de novo aneurysms where no stent was utilized.
  • Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).
  • Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.
  • Subject is eligible to undergo a procedure with the use of contrast media.
  • Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
  • Subject has given written informed consent.
  • Life expectancy > 12 months.

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Summary Exclusion Criteria:

  • Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.
  • Subject is currently undergoing radiation therapy.
  • Subject has known allergies to nickel-titanium metal.
  • Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.
  • Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
  • Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).
  • Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
  • Subject is currently participating in another clinical research study.
  • Subject has had a previous intracranial stenting procedure associated with the target aneurysm.
  • Subject is unable to complete the required follow-up.
  • Subject is pregnant or breastfeeding.(Females of childbearing potential must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
  • Subject has participated in a drug study within the last 30 days.
  • Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.
  • Extradural aneurysms.

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Treatment and study plan

Barrel™ Vascular Reconstruction Device (VRD)

Device

Intended for use with embolic coils for the treatment of wide-neck bifurcating or branch intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm, measured by 2D Digital Subtraction Angiography (DSA). Wide-neck is defined as having a neck width ≥ 4 mm or a dome-to-neck ratio < 2.

Primary outcomes

  1. Successful aneurysm occlusion with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure

    Time frame: 12 months

    Effectiveness measures are successful aneurysm treatment with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure in the absence of retreatment, parent artery stenosis (> 50%), or target aneurysm rupture.

    Safety measures are the absence of neurological death or major stroke at 12 months post treatment.

Secondary outcomes

  1. Successful delivery of the device measured by technical success.

    Time frame: At implant up to 30 days

    Technical success is defined as access to the lesion, successful deployment of the Barrel™ VRD and correct positioning of the device over the aneurysm.

Other outcomes

  1. Functional outcome

    Time frame: At 12 months

    Functional outcome as defined by modified Rankin Scale (mRS) at 12 months.

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study title

Multi-center Non-randomized Clinical Investigation of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide Neck Intracranial Bifurcation and Branch Aneurysms

Acronym: Barrel

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2014
Registry last updated
Jan 11, 2019

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.

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