CERUS
The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms
Clinical Question
Is the Contour Neurovascular System safe and effective for the treatment of unruptured intracranial bifurcation aneurysms?
Bottom Line
The Contour intrasaccular flow disruptor achieved technical success in 94% (32/34) of patients with bifurcation aneurysms. Complete occlusion (RR grade 1) was 47% at 6 months and 73% at 12 months (PP). Adequate occlusion (RR 1+2) was 84% at last follow-up. Primary safety (major stroke/death ≤30d or disabling stroke ≤6mo): 3/34 ITT (2 in patients who never received device). 30/32 PP patients were mRS 0 at 12 months. No deaths.
Major Points
- Technical success 94% (32/34). Complete occlusion: 47% at 6mo, 73% at 12mo (PP).
- Adequate occlusion (RR 1+2): 84% at last follow-up. Progressive improvement over time.
- Primary safety: 3/34 ITT but 2 events in patients who never received Contour (procedure-related).
- First planar (non-volumetric) intrasaccular device — sits at neck, not in dome.
- Only 4 device sizes needed (5-11mm). Sizing by neck width alone.
- Thromboembolic events: 11% (4/34); all nondisabling, resolved by next follow-up.
- 34 patients, 6 European centers, single-arm. No deaths at 12 months.
- Industry-independent study (no funding received).
Design
Study Type: Prospective, single-arm, multicenter study
Randomization:
Blinding: Independent imaging core lab and clinical events adjudication
Enrollment Period: October 2018 to July 2019
Follow-up Duration: 12 months
Centers: 6
Countries: Germany, Austria, Denmark
Sample Size: 34
Analysis: Intention-to-treat and per-protocol analyses
Inclusion Criteria
- Age 18 to 80 years
- Unruptured, untreated saccular bifurcation aneurysm
- Neck width 2–8 mm
- No adjunctive devices unless for bailout
Arms
| Field | Contour Arm |
|---|---|
| Intervention | Deployment of Contour Neurovascular System without adjunctive coiling |
| Duration | Single intervention with follow-up at 1, 6, and 12 months |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Complete aneurysm occlusion at 6 months (Raymond–Roy grade 1) | Primary | 47% | |||
| Complete occlusion at 12 months | Secondary | 73% | |||
| Adequate occlusion (RR 1+2) at 12 months | Secondary | 84% | |||
| Major Stroke or Death (30d) | Adverse | 2 | |||
| Minor Thromboembolic Events | Adverse | 4 | |||
| Unexplained SAH | Adverse | 1 |
Subgroup Analysis
None reported
Criticisms
- Small sample size (n=34)
- No randomization or control arm
- Limited generalizability due to expert operator experience
- COVID-19 disrupted 12-month imaging follow-up in some patients
Funding
No funding or financial support reported
Based on: CERUS (Neurosurgery, 2022)
Authors: Liebig T, Killer-Oberpfalzer M, Gal G, ..., Wodarg F
Citation: Neurosurgery. 2022 Mar;90(3):270-277. doi:10.1227/NEU.0000000000001783
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