NCT06485622

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arteriosclerosis Obliterans

Interventions

Type	Name	Description
PROCEDURE	open bypass group	After heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction.
PROCEDURE	bare metal stent group	Bare metal stent implantation during the index procedure.
PROCEDURE	plain old balloon angioplasty group	Only plain old balloon was used during the index procedure.
PROCEDURE	drug-coated balloon group	Drug-coated balloon was used during the index procedure.
PROCEDURE	directional atherectomy group	Directional atherectomy (with or without drug-coated balloon) during the index procedure.
PROCEDURE	hybrid repair group	Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-01
• Completion: 2029-07-01
• First posted: 2024-07-03
• Last updated: 2025-08-08

Locations

1 site across 1 country: China