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Pilot Study of the Contour Neurovascular SystemTM

Primary Purpose

Intracranial Aneurysm

Status

Terminated

Phase

Locations

Study Type

Interventional

Intervention

Contour Neurovascular System placement

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Brain, Intracranial Aneurysm Treatment, Endovascular Treatment, Brain Aneurysm, Neurovascular diseases, Aneurysms, Cerebrovascular Disorders, Central Nervous System Diseases, Vascular diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-80 years at screening
Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
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:

Ruptured IA
Any other IA that requires treatment in the next year
IA width >8.5 or <2 mm
IA neck >8 or <2 mm
IA minimum height <4mm
IA embolisation would most likely cause stroke
Target IA contains other devices/implants (e.g., coils)
Inability to access the target IA with the microcatheter
Any congenital or iatrogenic coagulopathy
Platelet count <50,000/microliter
Known allergy to platinum, nickel or titanium
Known allergy to contrast agents
Stenosis of the target IA's parent vessel >50%
Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm
Taking any anticoagulants (e.g., warfarin)
Abnormal clotting parameters
Pregnant, breastfeeding or planning pregnancy in the next 2 years
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contour Neurovascular System placement

Arm Description

Treatment of intracranial aneurysm with the Contour Neurovascular System device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02784431

First Posted

May 20, 2016

Last Updated

July 22, 2022

Sponsor

Cerus Endovascular, Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02784431

Brief Title

Pilot Study of the Contour Neurovascular SystemTM

Official Title

Pilot Study of the Contour Neurovascular SystemTM

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

To obtain clinical data in EU for CE Mark

Study Start Date

July 2016 (undefined)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cerus Endovascular, Ltd

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysm

Keywords

Brain, Intracranial Aneurysm Treatment, Endovascular Treatment, Brain Aneurysm, Neurovascular diseases, Aneurysms, Cerebrovascular Disorders, Central Nervous System Diseases, Vascular diseases

7. Study Design

Primary Purpose

Treatment

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contour Neurovascular System placement

Arm Type

Experimental

Arm Description

Treatment of intracranial aneurysm with the Contour Neurovascular System device.

Intervention Type

Device

Intervention Name(s)

Contour Neurovascular System placement

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Occlusion Status of the Target IA

Description

Time Frame

6 months (3 patients), 1 year (14 patients), 2 year (2 patients)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-80 years at screening Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2 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: Ruptured IA Any other IA that requires treatment in the next year IA width >8.5 or <2 mm IA neck >8 or <2 mm IA minimum height <4mm IA embolisation would most likely cause stroke Target IA contains other devices/implants (e.g., coils) Inability to access the target IA with the microcatheter Any congenital or iatrogenic coagulopathy Platelet count <50,000/microliter Known allergy to platinum, nickel or titanium Known allergy to contrast agents Stenosis of the target IA's parent vessel >50% Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm Taking any anticoagulants (e.g., warfarin) Abnormal clotting parameters Pregnant, breastfeeding or planning pregnancy in the next 2 years 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pilot Study of the Contour Neurovascular SystemTM

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