The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Centre hospitalier de l'université de Montréal
Montreal, Quebec, Canada
Stent expansion
Difference in minimal lumen diameter (MLD), minimal lumen area (MLA) and incomplete stent expansion as defined by C-arm CT between both groups
Time frame: At the completion of the intervention
Stent patency
Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation
Time frame: 1 year
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