NCT00718991

EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study

A Physician Initiated Prospective Multicenter Study on Excimer Laser Recanalisation in the Treatment of Long Infrapopliteal Lesions in Patients With Critical Limb Ischemia

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DEVICE	Spectranetics Turbo elite™ excimer laser catheter	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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-07-21
• Last updated: 2015-03-09

Locations

2 sites across 1 country: Belgium