Pilot Study of the Contour Neurovascular SystemTM

NCT ID: NCT02784431

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-10-31

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contour Neurovascular System placement

Treatment of intracranial aneurysm with the Contour Neurovascular System device.

Group Type: EXPERIMENTAL

Contour Neurovascular System placement

Intervention Type: DEVICE

Patients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.

Interventions

Contour Neurovascular System placement

Patients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerus Endovascular, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DNX065.A

Identifier Type: -

Identifier Source: org_study_id