Lower Extremity Arteriosclerosis Obliterans
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age >= 40 years; 2.No restrictions based on sex. 3.Diagnosis of atherosclerosis obliterans distal to the tibioperoneal trunk confirmed by Doppler ultrasound, characterized by: disappearance of the normal vascular wall structure, rigidity, enhanced echogenicity, densely arranged arterial calcified plaques within the occluded segment, and absence of blood flow signal in the lumen. 4.6-minute walk test distance <= 400 meters. 5.Fontaine Stage II. 6.Currently receiving standardized guideline-directed medical therapy; 7.Willing and able to provide voluntary, written informed consent;
Exclusion criteria
Exclusion criteria: 1.Presence of any contraindication to EECP: Uncontrolled hypertension (blood pressure >= 180/100 mmHg). Active bleeding disorders or bleeding tendency (e.g., platelet count 2.0). Uncontrolled tachyarrhythmia (e.g., atrial fibrillation, atrial flutter). Moderate to severe aortic regurgitation, aortic aneurysm, or active deep vein thrombosis of the lower limbs. Concurrent active systemic infection, pregnancy, or malignancy. Skin ulceration in the lower limb counterpulsation area, toe gangrene, or active acute infection/hemorrhage in the lower limbs. 2.iliac or femoral artery occlusion; 3.History of lower extremity arterial stenting; 4.Inability or unwillingness to provide written informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain-free walking distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Flow-Mediated Dilation (FMD);6-minute walk test distance;Peak systolic velocity and mean blood flow volume in the distal vasculature beyond the occluded segment, as measured by ultrasonography.;Ankle-Brachial Index (ABI) of the affected limb;Toe transcutaneous oxygen saturation (TcpO?) of the affected limb; | — |
Countries
China
Contacts
The Eighth Affiliated Hospital Sun Yat-sen University