Canadian eCLIPs™ Safety and Feasibility Study Protocol (CESIS)
|ClinicalTrials.gov Identifier: NCT01957683|
Recruitment Status : Unknown
Verified January 2014 by Evasc Medical Systems Corp..
Recruitment status was: Not yet recruiting
First Posted : October 8, 2013
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysms||Device: eCLIPs™ Family of Products||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||December 2014|
|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
- eCLIPs Bifurcation Remodelling System Technical Success [ Time Frame: 24 hours ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957683
|Contact: Michael EB. Kelly, PhD, MD, FRCSCemail@example.com|
|University of Alberta Hospital||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Saint Michael's Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Toronto Western Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|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|