Atherosclerosis, Ischemia
Conditions
Keywords
stents, atherectomy, femoral artery, popliteal artery
Brief summary
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
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)
Interventions
DEVICEplaque excision system
DEVICEballoon and Stent
Sponsors
Beijing Friendship Hospital
Beijing Chao Yang Hospital
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month Primary Patency Rate | 12 months | systolic velocity ratio \>2.4 as measured by Duplex ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 day | Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection. |
| freedom from clinically-driven TLR | 12 months | it is defined as thefreedom from clinically-driven target lesion revascularization |
| Major Adverse Events at 12-month Post Procedure | 12 months | 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-month Limb Salvage Rate | 12 months | Limb Salvage is defined as the freedom from secondary major amputation |
Countries
China
Outcome results
None listed