Canadian eCLIPs™ Safety and Feasibility Study Protocol

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intracranial Aneurysms

Intervention / Treatment
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* Device: eCLIPs™ Family of Products


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Device: eCLIPs™ Family of Products<br>* Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms<br>* Other names: eCLIPs™ Products;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysm, bifurcation, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum