Canadian eCLIPs™ Safety and Feasibility Study Protocol (CESIS)

A Multi-center Pilot Study Evaluating the Safety and Feasibility of the eCLIPs™ Family of Products for the Treatment of Unruptured Bifurcation Intracranial Aneurysms

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 Overview

• Status: Withdrawn
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: eCLIPs™ Family of Products

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1J 1Z4
    • Hôpital de l'Enfant-Jésus
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M5B 1W8
      • Saint Michael's Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

Only patients with the following characteristics are eligible for study entry:

1. Patient whose age is between 18 and 80 years old
2. 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
3. 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
4. Patient understands the nature of the procedure and has the capacity to provide informed consent.
5. 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:

1. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
2. Patient with an International Normalized Ratio (INR)≥ 1.5.
3. Patient with serum creatinine level ≥104 µmol/L at time of enrolment.
4. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
5. Patient who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation)
6. Patient with any condition which in the opinion of the treating physician would place the participant at a high risk of embolic stroke
7. Patient with known allergies to nickel-titanium metal
8. Patient with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
9. Patient with a life threatening allergy to contrast (unless treatment for allergy is tolerated)
10. Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
11. Patient who is currently participating in another clinical research study.
12. Patient who has had a previous intracranial stenting procedure associated with the target aneurysm.
13. Patient who is unable to complete the required follow-up.
14. Patient who is pregnant or breastfeeding.
15. Patient who has participated in a drug study within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: Bifurcation Remodeling Device; eCLIPs™ Microcatheter; eCLIPs™ Micro-Introducer; eCLIPs™ Detacher; eCLIPs™ Device; eCLIPs™ System; eCLIPs™ Products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eCLIPs Bifurcation Remodelling System Technical Success	The proportion of successful eCLIPs device implants at the target aneurysm.	24 hours
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.	30 day-6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
eCLIPs Microcatheter Technical Success	The proportion of procedures where the eCLIPs Microcatheter is able to access the target vasculature and successfully deliver the eCLIPs device.	24 hours
eCLIPs Micro-Introducer Technical Success	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.	24 hours
eCLIPs Detacher Technical Success	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.	24 hours
Measurement of aneurysm occlusion at 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.	6 months
Occurrence of unplanned aneurysm re-treatment within 6 months (endovascular or surgical repair).	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.	6 months
Assessment of Device Migration at 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.	6 months
Assessment of artery stenosis at the device location at 6 months	Branch arteries will be measured at baseline and compared radiographically at 6 months post procedure per review by the Independent neuroradiologist.	6 months
Assessment of artery patency at the target aneurysm at 6 months	Patency will be assessed radiographically at 6 month follow up and assessed by an independent neuroradiologist.	6 months
Determination of percentage of screened patients who are eligible for the study	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.	24 hours

Collaborators and Investigators

• Sponsor: Evasc Medical Systems Corp.
• Investigators: Principal Investigator: Michael EB Kelly, PhD, MD, FRCSC, FACS, Royal University Hospital, Saskatoon, Saskatchewan

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: endovascular treatment; stent; intracranial aneurysm; bifurcation; coil embolization; bare platinum; wide-neck; saccular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CS 13-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No