CompletedNot Applicable

The Reverse Barrel™ VRD Intracranial Aneurysm Trial

France20 participantsStarted 2013-12-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

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.

What they're measuring

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

Trial details

NCT IDNCT02125097

SponsorMedtronic Neurovascular Clinical Affairs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-12

View on ClinicalTrials.gov More Intracranial Aneurysms trials