Intracranial Aneurysm
Conditions
Brief summary
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ (Contour). The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.
Detailed description
Contour Neurovascular System™ European Pre-Market Unruptured Aneurysm Study (CERUS) initiated enrollment in October 2018 to assess the safety and effectiveness of the Contour Neurovascular System (Contour) in treatment of intracranial aneurysms (IA) with the intended indication for endovascular embolization of saccular IA. This prospective, single-arm, multicenter study was conducted to document the safety and performance of the Contour in treatment for patients with an IA.
Interventions
The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
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
Patients of all genders who meet all indications and contraindications will proceed to implantation. Inclusion criteria 1. Patient's indication for treatment of unruptured aneurysm is according to the national/international guidelines. 2. Age 18-80 years at screening 3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs 4. IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU 5. 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 6. Patient able to able to give their informed consent can be included in this study. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
Exclusion criteria
The presence of condition that may create unacceptable risk during the aneurysm embolization procedure, such as patients with: 1. Ruptured aneurysm 2. Patient anatomy or physiology considered unsuitable for endovascular treatment 3. Contraindication for arterial access 4. Largest measured IA equatorial diameter \>8.5 mm or \<2 mm 5. Largest measured IA neck diameter \>8 mm or \<2 mm 6. Target IA contains other devices/implants (e.g., coils) 7. Known allergy to platinum, nickel or titanium 8. Known allergy to contrast agents 9. Contraindication to anticoagulants or platelet inhibitor medication 10. Stenosis of the target IA's parent vessel \>50% 11. Anticoagulation medications such as warfarin that cannot be discontinued 12. Pregnant, breastfeeding or planning pregnancy in the next 2 years 13. Acute / chronic renal failure (including dialysis); Creatinine \> 2.00 mg/dl or \> 182 μmol/L 14. Myocardial Infarction, Stroke or TIA within the last 6 months 15. Any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc. 16. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.) 17. Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment. | 6 months | The Primary Safety Endpoint is the percentage of subjects with death of any non-accidental cause or any major disabling stroke within the first 30 days after treatment or major disabling stroke or death due to neurological cause from day 31 to 6 months after treatment. Major Disabling Stroke is defined as an episode of neurological signs or symptoms that persist beyond 24 hours accompanied with evidence of ischemia/infarction on imaging that results in an increase of NIHSS from baseline by \>= 4 points and/or an increase from mRS baseline by \>2. An independent Clinical Events Committee adjudicated all data used for safety endpoint analyses. |
| Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. | 6 months | The Primary Performance Endpoint was the percentage of subjects with complete aneurysm occlusion at 6 months as adjudicated by an independent core laboratory. Occlusion was assessed using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm). |
Countries
Austria, Denmark, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated All eligible patients who underwent an attempt with the Contour device.
Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unsuccessful Implant Attempt | 2 |
Baseline characteristics
| Characteristic | Treated | — |
|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 11.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 6 participants | — |
| Region of Enrollment Denmark | 6 participants | — |
| Region of Enrollment Germany | 22 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 9 / 34 |
| serious Total, serious adverse events | 13 / 34 |
Outcome results
Primary
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months.
The Primary Performance Endpoint was the percentage of subjects with complete aneurysm occlusion at 6 months as adjudicated by an independent core laboratory. Occlusion was assessed using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).
Time frame: 6 months
Population: Subjects with 6-month cerebral angiograms assessed by the core laboratory.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated | Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. | Class 1 | 14 Participants |
| Treated | Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. | Class 2 | 9 Participants |
| Treated | Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. | Class 3 | 6 Participants |
Primary
Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment.
The Primary Safety Endpoint is the percentage of subjects with death of any non-accidental cause or any major disabling stroke within the first 30 days after treatment or major disabling stroke or death due to neurological cause from day 31 to 6 months after treatment. Major Disabling Stroke is defined as an episode of neurological signs or symptoms that persist beyond 24 hours accompanied with evidence of ischemia/infarction on imaging that results in an increase of NIHSS from baseline by \>= 4 points and/or an increase from mRS baseline by \>2. An independent Clinical Events Committee adjudicated all data used for safety endpoint analyses.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated | Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment. | 1 Participants |