Pilot Study of the Contour Neurovascular SystemTM

Terminated

• Conditions: Intracranial Aneurysm
• Interventions: Device: Contour Neurovascular System placement

• Registration Number: NCT02784431
• Lead Sponsor: Cerus Endovascular, Ltd

Brief Summary

Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)

Detailed Description

Prospective, single-arm, multi-centre European study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA). Target aneurysms are unruptured aneurysms requiring endovascular treatment in the anterior and posterior cerebral circulation.

Study Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Start: 2016-07
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2021-04-30
• Results First Submitted QC: 2021-06-22
• Results First Posted: 2021-06-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18-80 years at screening
2. Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
3. IA appears suitable for Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements Patient able to understand and sign a study-specific informed consent form

Exclusion Criteria

1. Ruptured IA
2. Any other IA that requires treatment in the next year
3. IA width >8.5 or <2 mm
4. IA neck >8 or <2 mm
5. IA minimum height <4mm
6. IA embolisation would most likely cause stroke
7. Target IA contains other devices/implants (e.g., coils)
8. Inability to access the target IA with the microcatheter
9. Any congenital or iatrogenic coagulopathy
10. Platelet count <50,000/microliter
11. Known allergy to platinum, nickel or titanium
12. Known allergy to contrast agents
13. Stenosis of the target IA's parent vessel >50%
14. Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm
15. Taking any anticoagulants (e.g., warfarin)
16. Abnormal clotting parameters
17. Pregnant, breastfeeding or planning pregnancy in the next 2 years
18. Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.) or ability to comply with study requirements Participating in another study with investigational devices or drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contour Neurovascular System placement	Contour Neurovascular System placement	Treatment of intracranial aneurysm with the Contour Neurovascular System device.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.	6 months	Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.

Secondary Outcome Measures

Name	Time	Method
Occlusion Status of the Target IA	6 months (3 patients), 1 year (14 patients), 2 year (2 patients)	Last known occlusion status of the target IA as judged by an independent core laboratory using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).