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The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms

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Year of Publication: 2022

Authors: Liebig T, Killer-Oberpfalzer M, Gal G, ..., Wodarg F

Journal: Neurosurgery

Citation: Neurosurgery. 2022 Mar;90(3):270-277. doi:10.1227/NEU.0000000000001783

Link: https://doi.org/10.1227/neu.0000000000001783

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 14/30 (47%) at 6 months and, at 12 months, 15/21 (71%) actual PP or 22/30 (73%) with LOCF (abstract: 22/32 (69%)). Adequate occlusion (RR 1+2) was 84% at last follow-up. Primary safety endpoint (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 (RR1): 47% at 6mo; 71% at 12mo (PP actual), 73% with LOCF, 69% (22/32) per abstract.
Adequate occlusion (RR 1+2): 84% at last follow-up. Progressive improvement over time.
Primary safety endpoint met in 3/34 ITT but 2 events occurred in patients who never received the Contour (procedure-related, not device-related).
First planar (non-volumetric) intrasaccular device — sits at neck, not in dome.
Only 4 device sizes needed (5–11 mm). Sizing is performed to the aneurysm neck width and diameter (disregarding height).
Thromboembolic events: 11% (4/34); all nondisabling, resolved by next follow-up.
34 patients, 6 European centers, single-arm. No deaths at 12 months.
No external funding received, but participating centers were selected by the sponsor (Cerus Endovascular) and multiple authors report Cerus consulting/proctoring disclosures — not truly industry-independent.

      

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

Baseline Characteristics

Characteristic	Comorbidities	Qualifying Event
Hypertension	56
Diabetes	3
Hyperlipidemia	18
Prior Stroke	18
Smoker	47

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	Intervention
Composite primary endpoints: technical success, aneurysm occlusion at 6 months, and death or disabling stroke within 30 days/at 6 months.	Primary	Technical success 94% (32/34); RR1 occlusion at 6 mo 14/30 (47%); safety endpoint met in 3/34 ITT (2 in non-implanted patients).
Complete occlusion at 12 months (RR1, PP actual)	Secondary	15/21 (71%)
Complete occlusion at 12 months (RR1, LOCF)	Secondary	22/30 (73%)
Adequate occlusion (RR 1+2) at last follow-up	Secondary	84%
WOS complete occlusion (WOS 0) at 12 months (LOCF)	Secondary	20/30 (67%)
Retreatment during follow-up	Secondary	2 patients (1 ITT, 1 PP)
Major Stroke or Death (30d)	Adverse	3/34 ITT (2 in patients who never received Contour)
Minor Thromboembolic Events	Adverse	4 (all resolved by next follow-up)
Unexplained SAH	Adverse	1 (day 3, no clinical sequelae)

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
Participating centers were selected by the sponsor and most authors report Cerus Endovascular disclosures despite no direct study funding

Funding

No funding or financial support reported. However, participating centers were chosen by the sponsor (Cerus Endovascular) and multiple authors disclose consulting/proctoring relationships with Cerus.

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

Content summarized and formatted by NeuroTrials.ai.

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

• In 32 patients implanted with the Contour device, complete aneurysm occlusion (Raymond–Roy grade 1) at 12 months was 22/32 (69%) in the perprotocol group and 22/30 (73%) with last-observation-carried-forward.
• Technical success 94% (32/34); primary safety endpoint met in 3/34 ITT (2 events in patients who never received the Contour).
• Adequate occlusion (RR 1+2) reached 84% at last follow-up; no deaths at 12 months.
• Only 4 device sizes needed; sizing is performed to the aneurysm neck width and diameter (disregarding height), simplifying planning versus volumetric intrasaccular 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

• Technical success: 94% (32/34)
• Raymond-Roy (RR) Grade 1 (complete occlusion):
- 6 months: 14/30 (47%)
- 12 months: 15/21 (71%) PP actual; 22/30 (73%) with LOCF; 22/32 (69%) per abstract
• Adequate occlusion (RR 1+2): 84% at last follow-up
• WOS complete occlusion: 20/30 (67%) at 12 months (LOCF)
• Primary safety endpoint (major stroke/death ≤30d or disabling stroke ≤6mo): 3/34 ITT (2 in patients who never received the device)
• Minor thromboembolic events: 4 (all resolved)
• Retreatment: 2 patients
• No device-related deaths

Bottom Line

Major Points

Technical success 94% (32/34). Complete occlusion (RR1): 47% at 6mo; 71% at 12mo (PP actual), 73% with LOCF, 69% (22/32) per abstract.
Adequate occlusion (RR 1+2): 84% at last follow-up. Progressive improvement over time.
Primary safety endpoint met in 3/34 ITT but 2 events occurred in patients who never received the Contour (procedure-related, not device-related).
First planar (non-volumetric) intrasaccular device — sits at neck, not in dome.
Only 4 device sizes needed (5–11 mm). Sizing is performed to the aneurysm neck width and diameter (disregarding height).
Thromboembolic events: 11% (4/34); all nondisabling, resolved by next follow-up.
34 patients, 6 European centers, single-arm. No deaths at 12 months.
No external funding received, but participating centers were selected by the sponsor (Cerus Endovascular) and multiple authors report Cerus consulting/proctoring disclosures — not truly industry-independent.

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: Composite primary endpoints: technical success, aneurysm occlusion at 6 months, and death or disabling stroke within 30 days/at 6 months.

Control	Intervention	HR/OR	P-value
-	Technical success 94% (32/34); RR1 occlusion at 6 mo 14/30 (47%); safety endpoint met in 3/34 ITT (2 in non-implanted patients).	-

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
Participating centers were selected by the sponsor and most authors report Cerus Endovascular disclosures despite no direct study funding

Citation

Neurosurgery. 2022 Mar;90(3):270-277. doi:10.1227/NEU.0000000000001783

View Original Publication →

CERUS

The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Baseline Characteristics

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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