The Reverse Barrel™ VRD Intracranial Aneurysm Trial

NCT ID: NCT02125097

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-01
• Study Completion Date: 2015-12-12

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.

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intracranial Aneurysm Treatment

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.

Group Type: EXPERIMENTAL

Barrel™ Vascular Reconstruction Device (VRD)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Piotin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

Locations

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Countries

France

References

Gory B, Blanc R, Turjman F, Berge J, Piotin M. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study. J Neurointerv Surg. 2018 Oct;10(10):969-974. doi: 10.1136/neurintsurg-2017-013602. Epub 2018 Feb 2.

Reference Type: DERIVED

PMID: 29437935 (View on PubMed)

Other Identifiers

Barrel OUS VRD-001

Identifier Type: -

Identifier Source: org_study_id