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Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

RecruitingN/A

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Conditions: Arteriosclerosis Obliterans

Interventions: open bypass group, bare metal stent group, plain old balloon angioplasty group, drug-coated balloon group, directional atherectomy group

Countries: China

This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older, gender is not limited.
2. Patients diagnosed with arteriosclerosis obliterans.
3. Rutherford stages 2-6.
4. When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
5. Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.

Exclusion Criteria:

1. Malignant tumor
2. Alzheimer's disease
3. Blood disease or bleeding tendency
4. Heart Failure Grade III \~ IV
5. Pregnancy or lactation
6. An above-knee-below-knee amputation has been performed
7. Unable to accept therapeutic function tests
8. Life expectancy is less than six months
9. Combined with other diseases affecting walking
10. Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
11. Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant

Locations (1)

Guangzhou, Guangdong, China