Canadian eCLIPs™ Safety and Feasibility Study Protocol

NCT ID: NCT01957683

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-01-31

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.

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

eCLIPs™ Family of Products

Intervention Type: DEVICE

Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms

Interventions

eCLIPs™ Family of Products

Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms

Intervention Type: DEVICE

Other Intervention Names

Bifurcation Remodeling Device; eCLIPs™ Microcatheter; eCLIPs™ Micro-Introducer; eCLIPs™ Detacher; eCLIPs™ Device; eCLIPs™ System; eCLIPs™ Products

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evasc Medical Systems Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael EB Kelly, PhD, MD, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

Royal University Hospital, Saskatoon, Saskatchewan

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Saint Michael's Hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Hôpital de l'Enfant-Jésus

Québec, , Canada

Countries

Canada

Other Identifiers

CS 13-003

Identifier Type: -

Identifier Source: org_study_id