Peripheral Arterial Occlusive Disease Clinical Trial
Official title:
A Physician Initiated Prospective Multicenter Study on Excimer Laser Recanalisation in the Treatment of Long Infrapopliteal Lesions in Patients With Critical Limb Ischemia
This investigation is designed to assess the immediate and long-term angiographic patency
outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm)
infrapopliteal lesions in patients with critical limb ischemia (CLI)
The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular
devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters
transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the
obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser
catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing
diseased vessels.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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