Clinical trial NCT02179190: Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
Official title: Prospective, Multi-Center, Single-Arm Study of Reverse Medical Barrel™ Vascular Reconstruction Device for Adjunctive Treatment to Embolic Coils in Wide-Neck, Intracranial, Bifurcating Aneurysms of Middle Cerebral and Basilar Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Bifurcating Aneurysms
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2014-07-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.


Eligibility criteria: Inclusion Criteria:

1. Male or female between 18 and 85 years old.
2. A wide-neck de novo or non-de novo aneurysm.
3. Appropriate informed consent obtainable as determined by local IRB.
4. Life expectancy \> 24 months.

Exclusion Criteria:

1. Aneurysm rupture within 30 days of enrollment.
2. Bifurcating aneurysms not treatable with coiling.
3. Subject has platelet count of \<70,000.
4. Subject has known allergies to nickel-titanium metal.
5. Subject has known allergies to aspirin or heparin.
6. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
7. Subject is currently participating in another clinical research study.
8. Subject is pregnant or breastfeeding.
9. Subject has participated in a drug study within the last 30 days.
10. Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.

Primary outcomes:
measure: Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
timeFrame: 12 months, after device implant
measure: Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture
timeFrame: 12 months, after device implant
Secondary outcomes:
measure: Number of Participants With Successfully Deployed Barrel VRD
timeFrame: Index Procedure, Day 0
measure: Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months
timeFrame: 12 months, after device implant
measure: Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline
timeFrame: 12 months, after device implant
measure: Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75%
timeFrame: At 12 Months +/- 8 weeks
measure: Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks
timeFrame: 30 Days and 12 months +/- 8 weeks
Other outcomes:
measure: Number of Participants With Reported Device Related Serious Adverse Events
timeFrame: From the point of consent until participant exits the study at 1 year
Locations:
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami, BCVI
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: J Mocco, MD
role: PRINCIPAL_INVESTIGATOR
References: