Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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

Qualifiers

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 is included.

Disqualifiers

Malignant tumor

Alzheimer's disease

Blood disease or bleeding tendency

Heart Failure Grade III ~ IV

Trial design

Treatments tested in this trial

  • open bypass group
  • bare metal stent group
  • plain old balloon angioplasty group
  • drug-coated balloon group
  • directional atherectomy group
  • hybrid repair group

Treatment groups

400 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.