The Reverse Barrel™ VRD Intracranial Aneurysm Trial

NCT02125097 | Completed DMC

• 1 other identifier: Barrel OUS VRD-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysms

Keywords

Intracranial Aneurysm Treatment; Endovascular Therapy

Outcome Measures

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

  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.

  12 months

Secondary Outcomes (1)

• Successful delivery of the device measured by technical success.

  At implant up to 30 days

Other Outcomes (1)

• Functional outcome

  At 12 months

Study Arms (1)

Intracranial Aneurysm Treatment

EXPERIMENTAL

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)

Interventions

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.

Intracranial Aneurysm Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Gory B, Blanc R, Turjman F, Berge J, Piotin M. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study. J Neurointerv Surg. 2018 Oct;10(10):969-974. doi: 10.1136/neurintsurg-2017-013602. Epub 2018 Feb 2.

  PMID: 29437935 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Michel Piotin, M.D.

  Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 29, 2014
• Study Start: December 1, 2013
• Primary Completion: December 12, 2015
• Study Completion: December 12, 2015
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (1)