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The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrelâ„¢ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful aneurysm occlusion with the Barrelâ„¢ 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 Barrelâ„¢ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful delivery of the device measured by technical success. | Technical success is defined as access to the lesion, successful deployment of the Barrelâ„¢ VRD and correct positioning of the device over the aneurysm. | At implant up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Functional outcome as defined by modified Rankin Scale (mRS) at 12 months. | At 12 months |
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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| Name | Affiliation | Role |
|---|---|---|
| Michel Piotin, M.D. | Fondation Ophtalmologique Adolphe de Rothschild, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29437935 | Derived | 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. |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |