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临床试验/NCT05018949
NCT05018949Unknown不适用

Evaluation of Post-Angioplasty Outcomes

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Amputation Free Survival

研究概览

简要总结

There is no hard and fast rule guiding the clinical decision between angioplasty and amputation. As such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be conservative or aggressive.

Angioplasty can help restore blood flow and long-term patency of the blood vessels can help prevent major surgeries, such as amputation which affects patient's quality of life. However, some of these patients do not benefit from angioplasty and eventually had to undergo amputation. On the other hand, there are patients that undergo amputation, but may stand to benefit from angioplasty. Hence, it is essential to identify patients that will likely benefit from angioplasty to increase limb salvage rate. Many studies performed have also concluded that before amputations are performed, surgeons should consider angioplasty procedures.

Through a medical record review of patients that have undergone angioplasty to evaluate post-angioplasty outcomes, we hope to identify factors that potentially affects these outcomes. Ultimately with a better understanding of these factors and their impact on angioplasty outcomes, a predictive model or guideline can be developed to identify patients that stands to benefit from angioplasty. Such a model can help clinicians to better counsel patients on the risk and benefits, alternatives and prognosis. Patients can also make a better informed decision regarding their treatment

研究设计

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

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted into SGH Department of Vascular Surgery, and have successfully undergone angioplasty

排除标准

  • Minors under age of 21

结局指标

主要结局

Amputation Free Survival

时间窗: 12 months post-op

Freedom from major limb amputation

Freedom from target lesion revascularization

时间窗: 12 months post-op

Freedom from any interventions to the index treated lesion

Primary Patency

时间窗: 12 months

Patency of the treated lesion at index procedure

Wound healing rates

时间窗: 12 months

Healing of index wounds and whether there is any recurrence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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