Canadian eCLIPs™ Safety and Feasibility Study Protocol (CESIS)
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-center Pilot Study Evaluating the Safety and Feasibility of the eCLIPs™ Family of Products for the Treatment of Unruptured Bifurcation Intracranial Aneurysms|
- eCLIPs Bifurcation Remodelling System Technical Success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The proportion of successful eCLIPs device implants at the target aneurysm.
- No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months. [ Time Frame: 30 day-6 month ] [ Designated as safety issue: Yes ]A major stroke is defined as a new neurological event that persists for >24 hours and results in a 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
- eCLIPs Microcatheter Technical Success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The proportion of procedures where the eCLIPs Microcatheter is able to access the target vasculature and successfully deliver the eCLIPs device.
- eCLIPs Micro-Introducer Technical Success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The proportion of procedures where the eCLIPs Micro-Introducer successfully is used conjunction with the eCLIPs Microcatheter to assist in the delivery of the eCLIPs Microcatheter to the target aneurysm.
- eCLIPs Detacher Technical Success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The proportion of procedures where the eCLIPs Detacher is successfully used in conjunction with the eCLIPs Bifurcation Remodelling System to initiate detachment of the eCLIPs Device.
- Measurement of aneurysm occlusion at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Successful aneurysm treatment with the eCLIPs™ device and embolic coils, as measured by aneurysm occlusion of ≥ 70% (Meyers grade of 2 or less) at 6 month follow up as measured by using standard medical practice radiographic imaging of either angiography, magnetic resonance angiography (MRA), or computed tomography angiography (CTA). The type of follow-up imaging is determined at the discretion of the treating physician.
- Occurrence of unplanned aneurysm re-treatment within 6 months (endovascular or surgical repair). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]As determined by the treating physician, where the patient has a ≤70% aneurysm occlusion corresponding to a Meyer's aneurysm occlusion grade of greater than 2 and the treating physician judges the need for the re-treatment.
- Assessment of Device Migration at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Radiographic images will be comparing post procedure device position to 6 months position to determine if migration has occurred. Imaging from each participant will be reviewed by an independent neuroradiologist who will be comparing baseline.
- Assessment of artery stenosis at the device location at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Branch arteries will be measured at baseline and compared radiographically at 6 months post procedure per review by the Independent neuroradiologist.
- Assessment of artery patency at the target aneurysm at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Patency will be assessed radiographically at 6 month follow up and assessed by an independent neuroradiologist.
- Determination of percentage of screened patients who are eligible for the study [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The number of screened patients represents those patients reviewed by the investigator who have a known aneurysm and are considered for inclusion in the study. This represents the denominator of the proportion. The numerator will be the number of patients deemed eligible following the screening process.
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||
Device: eCLIPs™ Family of Products
Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms
With this other endoluminal stent/device implantation technique to treat intracranial aneurysms in conjunction with embolic coils, the neurovascular device is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment. The eCLIPs™ device manufactured by Evasc Medical Systems Corp. has a high density 'leaf' which is implanted across the bifurcation aneurysm neck and anchored in one of the branch arteries of the bifurcation and may provide improved bifurcation aneurysm treatment by allowing for a higher packing density of embolic coils implanted behind the eCLIPs™ device and the eCLIPs™ device in combination with embolic coils may reduce the recurrence/retreatment rate by increasing the rate of complete aneurysm occlusion.
|Contact: Michael EB. Kelly, PhD, MD, FRCSCfirstname.lastname@example.org|
|University of Alberta Hospital||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Toronto Western Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Saint Michael's Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Hôpital de l'Enfant-Jésus||Not yet recruiting|
|Québec, Quebec, Canada, G1J 1Z4|
|Royal University Hospital||Not yet recruiting|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Michael EB Kelly, PhD, MD, FRCSC, FACS||Royal University Hospital, Saskatoon, Saskatchewan|