Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Study Overview
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Brief Summary
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This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Detailed Description
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This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Official Title
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Occlusive Disease of Lower Extremity

Conditions
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Atherosclerosis, Ischemia

Intervention / Treatment
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* Device: plaque excision system
* Device: balloon and Stent


Participation Criteria
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Eligibility Criteria
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Patients were included if they were de novo stenosis>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford-Becker class II-III) or critical limb ischemia (Rutherford-Becker class IV-V). They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

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 |
| --- | --- |
| Active Comparator: Intervention: Stents<br>Stents group | Device: balloon and Stent<br> <br> |
| Active Comparator: Intervention: Atherectomy<br>directional atherectomy group | Device: plaque excision system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month Primary Patency Rate | systolic velocity ratio >2.4 as measured by Duplex ultrasound. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection. | 1 day | 
| freedom from clinically-driven TLR | it is defined as thefreedom from clinically-driven target lesion revascularization | 12 months | 
| Major Adverse Events at 12-month Post Procedure | Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage. | 12 months | 
| 12-month Limb Salvage Rate | Limb Salvage is defined as the freedom from secondary major amputation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stents, atherectomy, femoral artery, popliteal artery