The Reverse Barrel™ VRD Intracranial Aneurysm Trial

Intracranial Aneurysms Clinical Trial

— Barrel  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125097
• Other study ID #: Barrel OUS VRD-001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: December 12, 2015

Study information

• Verified date: January 2019
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

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.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

France, 

Outcome

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