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The Reverse Barrel™ VRD Intracranial Aneurysm Trial (Barrel)

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ClinicalTrials.gov Identifier: NCT02125097
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysms Device: Barrel™ Vascular Reconstruction Device (VRD) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intracranial Aneurysm Treatment
Barrel™ Vascular Reconstruction Device (VRD) is 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.
Device: Barrel™ Vascular Reconstruction Device (VRD)
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Functional outcome [ Time Frame: At 12 months ]
    Functional outcome as defined by modified Rankin Scale (mRS) at 12 months.



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

Summary Inclusion Criteria:

  1. Male or female ≥18 years old.
  2. 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.
  3. Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).
  4. Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.
  5. Subject is eligible to undergo a procedure with the use of contrast media.
  6. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
  7. Subject has given written informed consent.
  8. Life expectancy > 12 months.

Summary Exclusion Criteria:

  1. Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.
  2. Subject is currently undergoing radiation therapy.
  3. Subject has known allergies to nickel-titanium metal.
  4. Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.
  5. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
  6. Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).
  7. Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
  8. Subject is currently participating in another clinical research study.
  9. Subject has had a previous intracranial stenting procedure associated with the target aneurysm.
  10. Subject is unable to complete the required follow-up.
  11. 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.)
  12. Subject has participated in a drug study within the last 30 days.
  13. Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.
  14. Extradural aneurysms.


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): NCT02125097


Locations
France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
Principal Investigator: Michel Piotin, M.D. Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02125097     History of Changes
Other Study ID Numbers: Barrel OUS VRD-001
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Medtronic Neurovascular Clinical Affairs:
Intracranial Aneurysm Treatment
Endovascular Therapy

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases