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Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

NCT06485622 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-08-08

No results posted yet for this 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.

Conditions

  • Arteriosclerosis Obliterans

Interventions

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Zilun Li · First Affiliated Hospital, Sun Yat-Sen University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-31
Completion
2029-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485622 on ClinicalTrials.gov