Back to resultsCanadian eCLIPs™ Safety and Feasibility Study Protocol (CESIS)
Primary Purpose
Intracranial Aneurysms
Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
eCLIPs™ Family of Products
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysms focused on measuring intracranial aneurysm, bifurcation, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
Eligibility Criteria
Inclusion
Only patients with the following characteristics are eligible for study entry:
- Patient whose age is between 18 and 80 years old
- Patient with an unruptured, saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation and has a neck length of ≤ 6mm and aneurysm size of 5-35mm
- Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
- Patient understands the nature of the procedure and has the capacity to provide informed consent.
- Patient is willing to have on-site 30- day, and 6-month, follow-up evaluations as per standard clinical practice.
Exclusion Criteria:
Patients with the following characteristics are not eligible for study entry:
- Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- Patient with an International Normalized Ratio (INR)≥ 1.5.
- Patient with serum creatinine level ≥104 µmol/L at time of enrolment.
- Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
- Patient who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation)
- Patient with any condition which in the opinion of the treating physician would place the participant at a high risk of embolic stroke
- Patient with known allergies to nickel-titanium metal
- Patient with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
- Patient with a life threatening allergy to contrast (unless treatment for allergy is tolerated)
- Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
- Patient who is currently participating in another clinical research study.
- Patient who has had a previous intracranial stenting procedure associated with the target aneurysm.
- Patient who is unable to complete the required follow-up.
- Patient who is pregnant or breastfeeding.
- Patient who has participated in a drug study within the last 30 days.
Sites / Locations
- University of Alberta Hospital
- Saint Michael's Hospital
- Toronto Western Hospital
- Royal University Hospital
- Hôpital de l'Enfant-Jésus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
eCLIPs Bifurcation Remodelling System Technical Success
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01957683
First Posted
October 4, 2013
Last Updated
February 6, 2019
Sponsor
Evasc Medical Systems Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01957683
Brief Title
Canadian eCLIPs™ Safety and Feasibility Study Protocol
Acronym
CESIS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
insufficient funds
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evasc Medical Systems Corp.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
Keywords
intracranial aneurysm, bifurcation, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
eCLIPs™ Family of Products
Other Intervention Name(s)
Bifurcation Remodeling Device, eCLIPs™ Microcatheter, eCLIPs™ Micro-Introducer, eCLIPs™ Detacher, eCLIPs™ Device, eCLIPs™ System, eCLIPs™ Products
Intervention Description
Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms
Primary Outcome Measure Information:
Title
eCLIPs Bifurcation Remodelling System Technical Success
Description
The proportion of successful eCLIPs device implants at the target aneurysm.
Time Frame
24 hours
Title
No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.
Description
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.
Time Frame
30 day-6 month
Other Pre-specified Outcome Measures:
Title
eCLIPs Microcatheter Technical Success
Description
The proportion of procedures where the eCLIPs Microcatheter is able to access the target vasculature and successfully deliver the eCLIPs device.
Time Frame
24 hours
Title
eCLIPs Micro-Introducer Technical Success
Description
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.
Time Frame
24 hours
Title
eCLIPs Detacher Technical Success
Description
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.
Time Frame
24 hours
Title
Measurement of aneurysm occlusion at 6 months
Description
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.
Time Frame
6 months
Title
Occurrence of unplanned aneurysm re-treatment within 6 months (endovascular or surgical repair).
Description
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.
Time Frame
6 months
Title
Assessment of Device Migration at 6 months.
Description
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.
Time Frame
6 months
Title
Assessment of artery stenosis at the device location at 6 months
Description
Branch arteries will be measured at baseline and compared radiographically at 6 months post procedure per review by the Independent neuroradiologist.
Time Frame
6 months
Title
Assessment of artery patency at the target aneurysm at 6 months
Description
Patency will be assessed radiographically at 6 month follow up and assessed by an independent neuroradiologist.
Time Frame
6 months
Title
Determination of percentage of screened patients who are eligible for the study
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Only patients with the following characteristics are eligible for study entry:
Patient whose age is between 18 and 80 years old
Patient with an unruptured, saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation and has a neck length of ≤ 6mm and aneurysm size of 5-35mm
Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
Patient understands the nature of the procedure and has the capacity to provide informed consent.
Patient is willing to have on-site 30- day, and 6-month, follow-up evaluations as per standard clinical practice.
Exclusion Criteria:
Patients with the following characteristics are not eligible for study entry:
Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
Patient with an International Normalized Ratio (INR)≥ 1.5.
Patient with serum creatinine level ≥104 µmol/L at time of enrolment.
Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
Patient who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation)
Patient with any condition which in the opinion of the treating physician would place the participant at a high risk of embolic stroke
Patient with known allergies to nickel-titanium metal
Patient with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
Patient with a life threatening allergy to contrast (unless treatment for allergy is tolerated)
Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
Patient who is currently participating in another clinical research study.
Patient who has had a previous intracranial stenting procedure associated with the target aneurysm.
Patient who is unable to complete the required follow-up.
Patient who is pregnant or breastfeeding.
Patient who has participated in a drug study within the last 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael EB Kelly, PhD, MD, FRCSC, FACS
Organizational Affiliation
Royal University Hospital, Saskatoon, Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Hôpital de l'Enfant-Jésus
City
Québec
ZIP/Postal Code
G1J 1Z4
Country
Canada
12. IPD Sharing Statement
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Canadian eCLIPs™ Safety and Feasibility Study Protocol
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