Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

Phase

N/A

Condition

Intermittent Claudication

Vascular Diseases

Peripheral Vascular Disease

Treatment

drug-coated balloon group

open bypass group

hybrid repair group

Clinical Study ID

NCT06485622

[2024]225

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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, includingnon-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemicstroke and hemorrhagic stroke
Patients with significant abnormal liver and renal function that the investigatorsjudged to be clinically significant

Study Design

drug-coated balloon group

July 01, 2024

July 31, 2029

Study 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.

Connect with a study center

The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510030
China
Active - Recruiting

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