Peripheral Arterial Occlusive Disease
Conditions
Keywords
CLI, excimer laser, debulking
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.
Interventions
DEVICESpectranetics 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.
Sponsors
Spectranetics Corporation
Flanders Medical Research Program
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization | 12 months |
Countries
Belgium
Outcome results
None listed