The Reverse Barrel™ VRD Intracranial Aneurysm Trial
Study Details
Study Description
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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 [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
- Successful delivery of the device measured by technical success. [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
- Functional outcome [At 12 months]
Functional outcome as defined by modified Rankin Scale (mRS) at 12 months.
Eligibility Criteria
Criteria
Summary Inclusion Criteria:
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Male or female ≥18 years old.
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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.
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Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).
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Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.
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Subject is eligible to undergo a procedure with the use of contrast media.
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Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
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Subject has given written informed consent.
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Life expectancy > 12 months.
Summary Exclusion Criteria:
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Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.
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Subject is currently undergoing radiation therapy.
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Subject has known allergies to nickel-titanium metal.
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Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.
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Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
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Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).
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Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
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Subject is currently participating in another clinical research study.
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Subject has had a previous intracranial stenting procedure associated with the target aneurysm.
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Subject is unable to complete the required follow-up.
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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.)
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Subject has participated in a drug study within the last 30 days.
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Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.
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Extradural aneurysms.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Barrel OUS VRD-001