跳至主要内容
临床试验/NCT06485622
NCT06485622招募中不适用

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

First Affiliated Hospital, Sun Yat-Sen University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
2
主要终点
All cause mortality rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older, gender is not limited.
  • Patients diagnosed with arteriosclerosis obliterans.
  • Rutherford stages 2-
  • When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
  • Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.

排除标准

  • Malignant tumor
  • Alzheimer's disease
  • Blood disease or bleeding tendency
  • Heart Failure Grade III ~ IV
  • Pregnancy or lactation
  • An above-knee-below-knee amputation has been performed
  • Unable to accept therapeutic function tests
  • Life expectancy is less than six months
  • Combined with other diseases affecting walking
  • Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
  • Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant

研究组 & 干预措施

POBA group

POBA (plain old balloon angioplasty) group

干预措施: plain old balloon angioplasty group (Procedure)

DCB group

drug-coated balloon group

干预措施: drug-coated balloon group (Procedure)

DA group

DA (directional atherectomy) group

干预措施: directional atherectomy group (Procedure)

HR group

HR (hybrid repair) group

干预措施: hybrid repair group (Procedure)

Bypass group

open bypass group

干预措施: open bypass group (Procedure)

BMS group

BMS (bare metal stent) group

干预措施: bare metal stent group (Procedure)

结局指标

主要结局

All cause mortality rate

时间窗: 1 month; 6 months; 12 months; 24 months; 36 months

Death due to any cause.

Limb salvage rate

时间窗: 1 month; 6 months; 12 months; 24 months; 36 months

Freedom from above ankle amputation in target limb.

Primary patency rate

时间窗: 1 month; 6 months; 12 months; 24 months; 36 months

Primary patency of target lesion is assessed by the vascular ultrasound.

Major adverse limb event (MALE) rate

时间窗: 1 month; 6 months; 12 months; 24 months; 36 months

Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb.

次要结局

  • Restenosis of the target lesion(1 month; 6 months; 12 months; 24 months; 36 months)
  • Quality-adjusted life-years (QALYs)(1 month; 6 months; 12 months; 24 months; 36 months)
  • Major adverse cardiovascular events (MACE)(1 month; 6 months; 12 months; 24 months; 36 months)
  • Survival Rate(1 month; 6 months; 12 months; 24 months; 36 months)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zilun Li

Clinical Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (2)

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