Canadian eCLIPs™ Safety and Feasibility Study Protocol (CESIS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Evasc Medical Systems Corp.
Sponsor:
Information provided by (Responsible Party):
Evasc Medical Systems Corp.
ClinicalTrials.gov Identifier:
NCT01957683
First received: October 4, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Intracranial Aneurysms
Device: eCLIPs™ Family of Products
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Evasc Medical Systems Corp.:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 Enrollment: 30
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957683

Contacts
Contact: Michael EB. Kelly, PhD, MD, FRCSC m.kelly@usask.ca

Locations
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Saint Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Hôpital de l'Enfant-Jésus Not yet recruiting
Québec, Quebec, Canada, G1J 1Z4
Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Evasc Medical Systems Corp.
Investigators
Principal Investigator: Michael EB Kelly, PhD, MD, FRCSC, FACS Royal University Hospital, Saskatoon, Saskatchewan
  More Information

No publications provided

Responsible Party: Evasc Medical Systems Corp.
ClinicalTrials.gov Identifier: NCT01957683     History of Changes
Other Study ID Numbers: CS 13-003
Study First Received: October 4, 2013
Last Updated: January 21, 2014
Health Authority: Canada: Health Canada

Keywords provided by Evasc Medical Systems Corp.:
intracranial aneurysm
bifurcation
wide-neck
saccular
endovascular treatment
coil embolization
stent
bare platinum

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014