CERUS
(2022)Objective
Evaluate the safety and effectiveness of the Contour intrasaccular flow-disrupting device for the treatment of unruptured intracranial bifurcation aneurysms.
Study Summary
• Procedural success was 94%, with low periprocedural complication rates.
• Most adverse events were minor and resolved without long-term deficit.
• The device was easy to size and deploy, with minimal need for adjunctive devices.
Intervention
Prospective, multicenter, single-arm study across 6 European centers. N=34 patients with unruptured, untreated saccular bifurcation aneurysms (neck width 2–8 mm). 32 patients were treated with the Contour device. Imaging follow-up was conducted at 6 and 12 months. The Contour is a nonvolumetric, intrasaccular device made of braided nitinol wires, designed to disrupt flow at the aneurysm neck. Outcome measures included Raymond-Roy and WEB Occlusion Scale (WOS) scores.
Inclusion Criteria
• Age 18–80 years
• Saccular, unruptured bifurcation aneurysm with neck width 2–8 mm
• No adjunctive devices unless used for bailout
• No previous treatment of the target aneurysm
Study Design
Arms: Single-arm cohort (all patients treated with Contour)
Patients per Arm: 34 enrolled; 32 implanted (Per Protocol analysis); 30 available at 6-month follow-up; 21 at 12-month follow-up
Outcome
• Raymond-Roy (RR) Grade 1 (complete occlusion):
- 6 months: 47%
- 12 months: 71% (PP), 73% with LOCF
• Adequate occlusion (RR 1+2): 84% at 12 months
• WOS complete occlusion: 67% at 12 months (LOCF)
• Major stroke or disabling adverse event: 1 in PP group
• Minor thromboembolic events: 4 (all resolved)
• Retreatment: 2 patients
• No device-related deaths
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).
Study Design
- Study Type
- Prospective, single-arm, multicenter study
- Randomization
- No
- Blinding
- Independent imaging core lab and clinical events adjudication
- Sample Size
- 34
- Follow-up
- 12 months
- Centers
- 6
- Countries
- Germany, Austria, Denmark
Primary Outcome
Definition: Complete aneurysm occlusion at 6 months (Raymond–Roy grade 1)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | 47% | - |
Limitations & 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
Citation
Neurosurgery. 2022 Mar;90(3):270-277. doi:10.1227/NEU.0000000000001783