N/A
Completed N=138
Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
Intracranial Bifurcating Aneurysms
Source: ClinicalTrials.gov NCT02179190 ↗
Enrolled (actual)
138
Serious AEs
34.7%
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. — 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. |
5 | — |
| PRIMARY 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 |
67 | — |
| SECONDARY Number of Participants With Successfully Deployed Barrel VRD |
120 | — |
| SECONDARY 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 |
75 | — |
| SECONDARY Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline |
107 | — |
| SECONDARY 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% |
88; 1; 0; 0 | — |
| SECONDARY Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 and 85 years old.
- A wide-neck de novo or non-de novo aneurysm.
- Appropriate informed consent obtainable as determined by local IRB.
- Life expectancy > 24 months.
Exclusion Criteria
- Aneurysm rupture within 30 days of enrollment.
- Bifurcating aneurysms not treatable with coiling.
- Subject has platelet count of <70,000.
- Subject has known allergies to nickel-titanium metal.
- Subject has known allergies to aspirin or heparin.
- Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
- Subject is currently participating in another clinical research study.
- Subject is pregnant or breastfeeding.
- Subject has participated in a drug study within the last 30 days.
- Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.
Data sourced from ClinicalTrials.gov (NCT02179190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.