Canadian eCLIPs™ Safety and Feasibility Study Protocol

Phase 1

Withdrawn

• Conditions: Intracranial Aneurysms
• Interventions: Device: eCLIPs™ Family of Products

• Registration Number: NCT01957683
• Lead Sponsor: Evasc Medical Systems Corp.

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.

Study Timeline

• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08
• Study Start: 2020-01
• Primary Completion: 2021-12
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	eCLIPs™ Family of Products	-

Primary Outcome Measures

Name	Time	Method
No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.	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 Bifurcation Remodelling System Technical Success	24 hours	The proportion of successful eCLIPs device implants at the target aneurysm.

Trial Locations

Locations (5)

Saint Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Hôpital de l'Enfant-Jésus; 🇨🇦 Québec, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada