The Reverse Barrel™ VRD Intracranial Aneurysm Trial

Not Applicable

Completed

• Conditions: Intracranial Aneurysms
• Interventions: Device: Barrel™ Vascular Reconstruction Device (VRD)

• Registration Number: NCT02125097
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-01
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Primary Completion: 2015-12-12
• Study Completion: 2015-12-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracranial Aneurysm Treatment	Barrel™ Vascular Reconstruction Device (VRD)	Barrel™ Vascular Reconstruction Device (VRD) is 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.

Primary Outcome Measures

Name	Time	Method
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	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Successful delivery of the device measured by technical success.	At implant up to 30 days	Technical success is defined as access to the lesion, successful deployment of the Barrel™ VRD and correct positioning of the device over the aneurysm.

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France