NCT02125097

The Reverse Barrel™ VRD Intracranial Aneurysm Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysms

Interventions

Type	Name	Description
DEVICE	Barrel™ Vascular Reconstruction Device (VRD)	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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-12
• Completion: 2015-12-12
• First posted: 2014-04-29
• Last updated: 2019-01-11

Locations

1 site across 1 country: France