Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.

Study Overview
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Brief Summary
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This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Detailed Description
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This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Official Title
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Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

Conditions
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Critical Limb Ischemia, Infrapopliteal Lesions

Intervention / Treatment
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* Device: Excimer Laser Combined with DCB
* Device: Angioplasty Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The treatment vessel is DeNovo Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s) 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, superficial femoral, 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 a myocardial ischemia within 30 days prior to enrollment The patient has had a cardiovascular accident 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Excimer Laser Combined with DCB<br>Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia. | Device: Excimer Laser Combined with DCB<br>* Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.<br>|
| Active Comparator: Angioplasty Alone<br>Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia. | Device: Angioplasty Alone<br>* Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization rate | Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination. | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse events | Incidence of major adverse events (including operative-related arterial dissection, perforation, rupture, embolization, acute thrombosis, pseudoaneurysm, and hematoma formation). | 6-months | 
| Major amputation rate | The rate of major amputation. | 6-months | 
| Mortality | The ratio of deaths | 6-months | 
| Ankle Brachial Index |  | 6-months | 
| transcutaneous oxygen pressure |  | 6-months | 
| Wound healing wagner score (for patients with Rutherford classification 5) | Wound healing wagner score (for patients with Rutherford classification 5). | 6-months | 
| Length of hospital stay |  | 6-months | 
| hospitalization costs |  | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excimer Laser, Angioplasty, drug-coated baloons