WithdrawnPhase 1

Canadian eCLIPs™ Safety and Feasibility Study Protocol

Stopped: insufficient funds

Canada0Started 2020-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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

What they're measuring

eCLIPs Bifurcation Remodelling System Technical Success

Timeframe: 24 hours

No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.

Timeframe: 30 day-6 month

Trial details

NCT IDNCT01957683

SponsorEvasc Medical Systems Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Intracranial Aneurysms trials