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The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms. The eCLIPs device is a novel shield like implant that is placed across the neck of the aneurysm and not only facilitates coil retention but also partly obstructs the flow of blood into the aneurysm.
This is an early feasibility study, which is a small study investigating an innovative device to gather more clinical data before conducting a larger study. The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers. A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms.
The primary objective of this study is to obtain preliminary confirmation that the eCLIPs Delivery Wire is safe and provides sufficient technical performance in delivering the eCLIPs Implant to distal tortuous anatomies.
This study will be a multicentre, open label, single-arm safety, technical performance, and efficacy study of the Electrolytic eCLIPs Bifurcation System in the management of bifurcated intracranial aneurysms (IA). Subjects included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation, having a neck length of ≥ 4mm or have a dome:neck ratio <2. Aside from the implantation of the eCLIPs Implant, the study will follow usual clinical care practices.
The subjects will undergo clinical assessments at pre-discharge and 30 days, as well as clinical assessment and radiographic imaging at 6 and 12 months (Digital Subtraction Angiography; DSA).
It is important to note that changes to the investigational device may occur during the course of this early feasibility study. Ongoing results of the study will be evaluated, along with collection of detailed operator feedback on usability, in order to determine whether further refinements to the eCLIPs Delivery Wire are required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Single arm study - treatment with Electrolytic eCLIPs Bifurcation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrolytic eCLIPs Bifurcation System | Device | The electrolytic eCLIPs bifurcation system will be implanted into patients with bifurcated saccular intra-cranial aneurysms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events following the eCLIPs procedure | Proportion of subjects experiencing a device-related serious adverse event within 30 days following the procedure | Within 30 days of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Proportion of subjects with procedural success for the Electrolytic eCLIPs Bifurcation System. Procedural success defined as: access to the aneurysm, successful deployment, implantation of the eCLIPs Implant, and successful neck bridging of the target aneurysm, as judged by core lab evaluation of the procedural angiogram. | During Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Success of adjuvant coiling | Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs Implant, and the eCLIPs Implant to satisfactorily retain coils; irrespective of coil density or degree of occlusion. | During Procedure |
| Aneurysm Occlusion | Proportion of subjects with successful aneurysm treatment with the eCLIPs Implant and embolic coils, as measured by aneurysm occlusion of Modified Raymond-Roy Classification of 1 (no aneurysmal opacification) or 2 (residual neck) using DSA | At 6 month and 12 month follow-up |
| Major ipsilateral stroke or neurologic death | Proportion of subjects experiencing major stroke of neurologic death within 30 days, 6 and 12 months following the procedure. | Within12 months of procedure |
| All device-related adverse events (AEs) | A quantitative and descriptive summary of all device-related AEs experienced within 30 days, 6 and 12 months following the procedure. | Within 12 months of procedure |
| Deterioration in modified Rankin Scale (mRS) score at Follow up | Proportion of subjects experiencing deterioration of modified Rankin Scale (mRS) score from baseline to 30 days, 6 and 12 month follow-up. Neurologic evaluation must be performed by independent qualified personnel. | 30 days, 6, and 12 months following the procedure |
| Assessment of implant migration | Proportion of subjects with implant migration at 6 and 12 months follow up. Migration is defined as movement of the eCLIPs implant by 5mm compared to the position at implantation per core lab evaluation. | 6 and 12 months following procedure |
| Assessment of branch artery patency | Proportion of subjects whose branch arteries (of the target aneurysm) are patent at 6 and 12 month follow up per core lab evaluation. | 6 and 12 months following procedure |
| Patient Outcomes - Hospitalization length of stay (LOS) | Mean hospitalization LOS for index procedure. | Within 12 months of procedure |
| Patient Outcomes - Subsequent hospitalization | Proportion of subjects requiring any subsequent hospitalization related to the index aneurysm. | Within 12 months of procedure |
| Patient Outcomes - Remedial actions required | Proportion of subjects requiring remedial action for an adverse event during index procedure. | Within 12 months of procedure |
| Patient Outcomes - Reintervention required | Proportion of subjects with complications, neurologic deterioration or adverse events requiring reintervention. | 30 days, 6, and 12 months following the procedure |
| Patient Outcomes - Return to baseline or improved functioning | Proportion of subjects returning to baseline functioning or improved functioning as measured by modified Rankin Scale (mRS). Baseline mRS compared to mRS at follow up. | 6 and 12 months following procedure |
| Patient Outcomes - Aneurysm recurrence | Proportion of subjects with index aneurysm recurrence. | Within 30 days, 6, and 12 months following the procedure |
| Patient Outcomes - Aneurysm rupture | Proportion of subjects with index aneurysm rupture. | Within 30 days, 6, and 12 months following the procedure |
| Patient Outcomes - Neurologic deterioration | Proportion of subjects with neurologic deterioration pre-discharge. | Immediate post-procedure prior to discharge |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |