Intracranial Aneurysms Clinical Trial
— BarrelOfficial 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
Verified date | January 2019 |
Source | Medtronic Neurovascular Clinical Affairs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 12, 2015 |
Est. primary completion date | December 12, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Medtronic Neurovascular Clinical Affairs |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Functional outcome | Functional outcome as defined by modified Rankin Scale (mRS) at 12 months. | At 12 months | |
Primary | 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 | 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. | At implant up to 30 days |
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