RecruitingNCT06485622

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

400 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Arteriosclerosis Obliterans

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called bare metal stent group, a procedure called directional atherectomy group, and others for people with arteriosclerosis obliterans. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREopen 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.

PROCEDUREbare metal stent group

Bare metal stent implantation during the index procedure.

PROCEDUREplain old balloon angioplasty group

Only plain old balloon was used during the index procedure.

PROCEDUREdrug-coated balloon group

Drug-coated balloon was used during the index procedure.

PROCEDUREdirectional atherectomy group

Directional atherectomy (with or without drug-coated balloon) during the index procedure.

PROCEDUREhybrid 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

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NCT06485622