The Reverse Barrel™ VRD Intracranial Aneurysm Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Reverse Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Reverse Medical Corporation
ClinicalTrials.gov Identifier:
NCT02125097
First received: April 22, 2014
Last updated: July 5, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Intracranial Aneurysms
Device: Barrel™ Vascular Reconstruction Device (VRD)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Reverse Medical Corporation:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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:
  • Successful delivery of the device measured by technical success. [ Time Frame: At implant up to 30 days ] [ Designated as safety issue: Yes ]
    Technical success is defined as access to the lesion, successful deployment of the Barrel™ VRD and correct positioning of the device over the aneurysm.


Other Outcome Measures:
  • Functional outcome [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    Functional outcome as defined by modified Rankin Scale (mRS) at 12 months.


Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125097

Contacts
Contact: Jeff Valko 949-633-2747 JValko@reversemed.com
Contact: Linda Nicolini +33 1 62196428 lnicolini@reversemed.com

Locations
France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Michel Piotin, M.D.    +33 1 48036831    michel.piotin@me.com   
Contact: Raphael Blanc, M.D.    +33 1 48036831    rblanc29@gmail.com   
Principal Investigator: Michel Piotin, M.D.         
Sponsors and Collaborators
Reverse Medical Corporation
Investigators
Principal Investigator: Michel Piotin, M.D. Fondation Ophtalmologique Adolphe de Rothschild, Paris, France
  More Information

No publications provided

Responsible Party: Reverse Medical Corporation
ClinicalTrials.gov Identifier: NCT02125097     History of Changes
Other Study ID Numbers: Barrel OUS VRD-001
Study First Received: April 22, 2014
Last Updated: July 5, 2014
Health Authority: France: French National Agency for Drugs and Health Products (ANSM)

Keywords provided by Reverse Medical Corporation:
Intracranial Aneurysm Treatment
Endovascular Therapy

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014