Intracranial Aneurysm
Conditions
Keywords
Brain, Intracranial Aneurysm Treatment, Endovascular Treatment, Brain Aneurysm, Neurovascular diseases, Aneurysms, Cerebrovascular Disorders, Central Nervous System Diseases, Vascular diseases
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.
Interventions
DEVICEContour 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.
Sponsors
Cerus Endovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment. | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Occlusion Status of the Target IA | 6 months (3 patients), 1 year (14 patients), 2 year (2 patients) | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Study Termination | 19 |
| Overall Study | Unsuccessful Implant Attempt | 1 |
Baseline characteristics
| Characteristic | Treated |
|---|---|
| Age, Continuous | 65 years |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Turkish | 2 Participants |
| Race/Ethnicity, Customized White | 16 Participants |
| Region of Enrollment Hungary | 2 Participants |
| Region of Enrollment United Kingdom | 18 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 10 / 19 |
| serious Total, serious adverse events | 4 / 19 |
Outcome results
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.
Time frame: 6 months
Population: Patients who were successfully implanted with the Contour device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated | Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment. | 0 Participants |
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).
Time frame: 6 months (3 patients), 1 year (14 patients), 2 year (2 patients)
Population: Patients successfully implanted with the Contour device.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated | Occlusion Status of the Target IA | Class 1 | 11 Participants |
| Treated | Occlusion Status of the Target IA | Class 2 | 3 Participants |
| Treated | Occlusion Status of the Target IA | Class 3 | 5 Participants |