Pilot Study of the Contour Neurovascular SystemTM

Cerus

Status: Terminated

Conditions: Intracranial Aneurysm

Treatments: Device: Contour Neurovascular System placement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02784431

DNX065.A

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Contour Neurovascular System placement

Experimental group

Description:

Treatment of intracranial aneurysm with the Contour Neurovascular System device.

Treatment:

Device: Contour Neurovascular System placement