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Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
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.
Official title: Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2024-07-01
Completion Date
2029-07
Last Updated
2025-08-08
Healthy Volunteers
No
Conditions
Interventions
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.
bare metal stent group
Bare metal stent implantation during the index procedure.
plain old balloon angioplasty group
Only plain old balloon was used during the index procedure.
drug-coated balloon group
Drug-coated balloon was used during the index procedure.
directional atherectomy group
Directional atherectomy (with or without drug-coated balloon) during the index 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.
Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China