Clinical trial NCT06485622: Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
Official title: Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arteriosclerosis Obliterans
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lower extremity arteriosclerosis obliterans

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.

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

Primary outcomes:
measure: Limb salvage rate
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Primary patency rate
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Major adverse limb event (MALE) rate
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: All cause mortality rate
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
Secondary outcomes:
measure: Restenosis of the target lesion
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Major adverse cardiovascular events (MACE)
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Quality-adjusted life-years (QALYs)
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Survival Rate
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
Other outcomes:
measure: Clinically-driven target lesion revascularization (CD-TLR)
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Wound healing
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Incremental cost effectiveness ratio (ICER)
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Improvement of dietary and life style
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Cost effectiveness acceptability curve
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
measure: Ankle brachial index (ABI)
timeFrame: 1 month; 6 months; 12 months; 24 months; 36 months
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Zilun Li
role: PRINCIPAL_INVESTIGATOR
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