Intracranial Aneurysm
Conditions
Brief summary
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy. The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms (IA).
Detailed description
Neqstent is designed as an adjunctive therapy for patients with unruptured and failed bifurcation aneurysm embolizations. Neqstent can be positioned at the neck of the aneurysm with or without existing coils and other embolization products. Embolization coils should be added to fill the dome of the aneurysm after placement of Neqstent.
Interventions
DEVICENeqstent
Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
Sponsors
Cerus Endovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single arm, multi-center study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient's indication for treatment of unruptured IAs 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
1. Ruptured aneurysm 2. Patient anatomy or physiology considered unsuitable for endovascular treatment 3. Any patient anatomy, physiology, existing implants with failed aneurysm embolization that would interfere with the ability for Neqstent to seal at the neck of the aneurysm. (i.e., compacted coils in close proximity to the neck that prevent good apposition of the Neqstent to the wall of the aneurysm, stent and/or stent-like devices whose struts span the aneurysm neck to retain the coil mass that inhibit access and/or successful Neqstent seating at the aneurysm neck, and/or any aneurysm that has a failed device and confirmed thrombus-burden inside the aneurysm sac) 4. Contraindication for arterial access 5. Largest measured IA neck diameter \>8 mm or \<3 mm 6. Target IA contains other devices/implants (e.g., coils) that will prevent complete expansion of Neqstent 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 women of childbearing potential not on adequate birth control (only women with a highly effective method of contraception \[oral contraception or intra-uterine device\] or sterile women can be enrolled to the study) 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 18. The presence of condition that may create unacceptable risk during the aneurysm embolization procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause. | From day 31 to 6 months after treatment | — |
| The Proportion of Subjects With Complete Occlusion | 6 months | Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale. |
Countries
Austria, Canada, Denmark, Germany, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention/Neqstent Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Intervention/Neqstent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment Austria | 2 Participants |
| Region of Enrollment Canada | 5 Participants |
| Region of Enrollment Denmark | 17 Participants |
| Region of Enrollment Germany | 13 Participants |
| Region of Enrollment Switzerland | 1 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 37 |
| other Total, other adverse events | 19 / 37 |
| serious Total, serious adverse events | 15 / 37 |
Outcome results
Primary
The Proportion of Subjects With Complete Occlusion
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
Time frame: 6 months
Population: Intent-to-treat: All eligible subjects who underwent an attempt with the Neqstent device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention/Neqstent | The Proportion of Subjects With Complete Occlusion | 26 Participants |
Primary
The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause.
Time frame: From day 31 to 6 months after treatment
Population: Intent-to-treat: All eligible subjects who underwent an attempt with the Neqstent device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention/Neqstent | The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause. | 2 Participants |