Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arteriosclerosis Obliterans
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- All cause mortality rate
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
Arteriosclerosis obliterans (ASO) is a kind of lower extremity arterial disease which occurs frequently in middle-aged and elderly people. The incidence of ASO increases with age. In patients with ASO, the build-up of fatty deposits, cholesterol, and other substances (plaques) in the arteries reduces blood flow to the extremities. This can lead to symptoms such as leg pain, cramping, and fatigue, especially during physical activity. In severe cases, it may result in pain at rest, non-healing wounds, and complications such as tissue damage or infection. Chronic wound is one of the symptoms that affect the quality of life. Therefore, wound healing is also an important index for postoperative care. However, no study has reported detailed performance data for different treatments. As an auxiliary method in clinical treatment, nutrition plays an important role in improving the clinical outcome of patients in the development and postoperative stages of the disease. The effect of nutritional risk assessment and nutritional education on postoperative symptoms of ASO has not been reported. Therefore, we plan to carry out this prospective, single-center, observational study, providing new data on the efficacy, safety and cost-effectiveness for different treatment and assistive techniques in lower extremity arterial occlusive disease.
Investigators
Zilun Li
Clinical Professor
First Affiliated Hospital, Sun Yat-Sen University
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older, gender is not limited.
- •Patients diagnosed with arteriosclerosis obliterans.
- •Rutherford stages 2-
- •When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
- •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
- •Malignant tumor
- •Alzheimer's disease
- •Blood disease or bleeding tendency
- •Heart Failure Grade III \~ IV
- •Pregnancy or lactation
- •An above-knee-below-knee amputation has been performed
- •Unable to accept therapeutic function tests
- •Life expectancy is less than six months
- •Combined with other diseases affecting walking
- •Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
Outcomes
Primary Outcomes
All cause mortality rate
Time Frame: 1 month; 6 months; 12 months; 24 months; 36 months
Death due to any cause.
Limb salvage rate
Time Frame: 1 month; 6 months; 12 months; 24 months; 36 months
Freedom from above ankle amputation in target limb.
Primary patency rate
Time Frame: 1 month; 6 months; 12 months; 24 months; 36 months
Primary patency of target lesion is assessed by the vascular ultrasound.
Major adverse limb event (MALE) rate
Time Frame: 1 month; 6 months; 12 months; 24 months; 36 months
Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb.
Secondary Outcomes
- Restenosis of the target lesion(1 month; 6 months; 12 months; 24 months; 36 months)
- Quality-adjusted life-years (QALYs)(1 month; 6 months; 12 months; 24 months; 36 months)
- Major adverse cardiovascular events (MACE)(1 month; 6 months; 12 months; 24 months; 36 months)
- Survival Rate(1 month; 6 months; 12 months; 24 months; 36 months)