Pilot Study of the Contour Neurovascular SystemTM

Intracranial Aneurysm Clinical Trial

Official title:

Pilot Study of the Contour Neurovascular SystemTM

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02784431
• Other study ID #: DNX065.A
• Status: Terminated
• Start date: July 2016
• Est. completion date: October 2018

Study information

• Verified date: July 2022
• Source: Cerus Endovascular, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cerus Endovascular, Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.	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.	6 months
Secondary	Occlusion Status of the Target IA	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).	6 months (3 patients), 1 year (14 patients), 2 year (2 patients)