The Reverse Barrel™ VRD Intracranial Aneurysm Trial

Medtronic Neurovascular Clinical Affairs20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intracranial Aneurysms

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Successful delivery of the device measured by technical success.

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

Time frame: At implant up to 30 days

Data from ClinicalTrials.gov

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