Pilot Study of the Contour Neurovascular SystemTM

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

Study Overview

• Status: Terminated
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Contour Neurovascular System placement

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 Type: Interventional
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contour Neurovascular System placement; Treatment of intracranial aneurysm with the Contour Neurovascular System device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Cerus Endovascular, Ltd

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Brain; Central Nervous System Diseases; Vascular diseases; Cerebrovascular Disorders; Aneurysms; Endovascular Treatment; Brain Aneurysm; Intracranial Aneurysm Treatment; Neurovascular diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: DNX065.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO