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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Peripheral Arterial Occlusive Disease

Intervention / Treatment
-----------------
* Device: Spectranetics Turbo elite™ excimer laser catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The treatment vessel is DeNovo Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s) Length of target lesion is > 50 mm Reference target vessel diameter between 2-4.0 mm by visual assessment Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia The patient must be >18 years of age Life-expectancy of more than 12 months The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure The patient must be willing and able to return to the appropriate follow-up times for the duration of the study The patient must provide written patient informed consent that is approved by the ethics committee Anatomic Inclusion Criteria All inflow lesions successfully (<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications At least one angiographically visible target at the ankle for establishment of straight line flow. Exclusion Criteria: Patient refusing treatment The target vessel segment diameter is not suitable for available catheter design. Unsuccessfully treated endovascular or bypass( >30% residual stenosis) proximal ( iliac, SFA, popliteal) inflow limiting arterial/graft stenosis Lesion lies within or adjacent to an aneurysm The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies. The patient has a history of prior life-threatening contrast media reaction. The patient is currently enrolled in another investigational device or drug trial. The patient is currently breast-feeding, pregnant or intends to become pregnant. The patient is unable to provide informed consent The patient has end stage renal disease (currently on any form of dialysis) Known Left Ventricular Ejection Fraction < 35% The patient has had an MI within 30 days prior to enrollment The patient has had a CVA within 90 days prior to enrollment Serum Creatinine > 150 µmol The patient has a previous bypass in the target limb The patient has a current systemic infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions | Device: Spectranetics Turbo elite™ excimer laser catheter<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot |  | 12 months | 
| Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate angiographic laser recanalization success + PTA, defined as a residual diameter stenosis ≤30% and absence of flow-limiting dissection on visual assessment after combined excimer laser and PTA recanalization treatment |  | Procedure | 
| Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization |  | 12 months | 
| Limb-salvage rate at all follow-up visits, defined as lack of major amputation of treated limb. Limb-salvage rate (LSR) is defined as 1 minus major amputation rate |  | 12 months | 
| Serious adverse events defined as being fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged or new hospitalization |  | 12 months | 
| Clinical success at follow-up is defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification |  | 12 months | 
| Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLI, excimer laser, debulking