Soundbite Crossing System Peripheral First in Man (NCT03013088) | Clinical Trial Compass
CompletedNot Applicable
Soundbite Crossing System Peripheral First in Man
Canada37 participantsStarted 2016-12
Plain-language summary
This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in the lower extremity arteries without major adverse events related to SoundBite device utilization.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Symptomatic target leg ischemia, requiring treatment of an infrainguinal artery.
ā. Rutherford Category of 2-5.
ā. ā„ 18 years of age.
ā. Life expectancy \> 1 year.
ā. Able and willing to provide written informed consent prior to study procedure.
ā. Evidence that the target CTO lesion is a de novo or restenotic chronic total occlusion in the SFA (starting at least 1cm distal to the origin of the SFA) and/or popliteal artery (ending at least 1cm proximal to the popliteal trifurcation), confirmed by angiography; AND/OR Evidence that the target CTO lesion is a de novo or restenotic chronic total occlusion and is located below the popliteal trifurcation in the anterior tibial, posterior tibial or peroneal arteries (at least 1 cm distal to the vessel origin, and ending at least 1cm proximal to the dorsalis pedis or plantar arteries), confirmed by angiography.
ā. Target CTO lesion is 100% occluded by visual estimate.
ā. Target limb has at least one patent (\<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
Exclusion criteria
ā. History of previous peripheral bypass or stent placement, affecting the target CTO lesion (i.e. target CTO lesion (de novo or restenotic) must be at least 1cm proximal or distal to a surgical bypass graft anastomosis or stent edge to be eligible for treatment).