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Sponsors and Collaborators: |
Flanders Medical Research Program Spectranetics Corporation |
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Information provided by: | Flanders Medical Research Program |
ClinicalTrials.gov Identifier: | NCT00718991 |
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.
Condition | Intervention | Phase |
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Peripheral Arterial Occlusive Disease |
Device: Spectranetics Turbo elite™ excimer laser catheter |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Anatomic Inclusion Criteria
Exclusion Criteria:
Contact: Patrick Peeters, MD | +3215506197 | patrick.peeters@imelda.be |
Contact: Koen De Meester | +3252252822 | koen.demeester@fmrp.be |
Belgium | |
Imelda Hospital | |
Bonheiden, Belgium, 2820 | |
AZ St-Blasius | |
Dendermonde, Belgium, 9200 |
Principal Investigator: | Patrick Peeters, MD | Imelda Hospital, Bonheiden, Belgium |
Principal Investigator: | Marc Bosiers, MD | AZ St-Blasius, Dendermonde, Belgium |
Responsible Party: | Flanders Medical Research Program ( Flanders Medical Research Program ) |
Study ID Numbers: | FMRP-005 |
Study First Received: | July 18, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00718991 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
CLI excimer laser debulking |
Arterial Occlusive Diseases Vascular Diseases Ischemia |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |