Clinical trial NCT02125097: The Reverse Barrel™ VRD Intracranial Aneurysm Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysms
Keywords: Intracranial Aneurysm Treatment
Endovascular Therapy
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

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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.

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Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Successful delivery of the device measured by technical success.
timeFrame: At implant up to 30 days
Other outcomes:
measure: Functional outcome
timeFrame: At 12 months
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild, Paris, France
name: Michel Piotin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.