Clinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.
Peripheral Arterial Disease (PAD) restricts blood supply to the lower limbs. The disease causes obstructions that can affect blood vessels in both the proximal and distal regions. When these vessel obstructions exist for more than 3- 6 Months they are classed as chronic total occlusions. Without sufficient collateral formation this can lead to to chronic limb-treatening ischemia (CLTI), which is characterized by chronic pain and tissue loss. Without revascularization this frequently leads to amputation. The purpose of this clinical study is to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature with the URECA CTO device.
Ikazia ziekenhuis
Rotterdam, South Holland, Netherlands
device success,
the successful placement of a guidewire in the true lumen distal of the CTO using the URECA CTO Device without the occurrence of device related complications that involve a Serious Adverse Event.
Time frame: during surgery
safety of device
absence of device related Serious Adverse Events.
Time frame: 6 weeks after surgery
Adverse Events
device related complications that involve a Adverse Event.
Time frame: 6 weeks after surgery
procedure time
time whole procedure takes using the URECA CTO device
Time frame: during surgery
Total Fluoroscopy Time and
The amount of time of fluoroscopy between the time of introducer sheath puncture up to the moment of sheath removal
Time frame: during surgery
Total Contrast Load
the amount of contrast load between the time of introducer sheath puncture up to the moment of sheath removal
Time frame: during surgery
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