Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Transcutaneous oxygen pressure
研究概览
简要总结
In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).
详细描述
Arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (PAD). Quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. Not only in PAD patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. Digital subtraction angiography (DSA) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. However, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. In this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.
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
- 否
入选标准
- •patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization.
排除标准
- •patients younger than 18 years
- •patients unable to give consent without legal guardians
- •iodine allergy
- •hyperthyroidism
- •allergy to indocyanine green
- •Glomerular filtration rate <30ml/min/1.73m2
结局指标
主要结局
Transcutaneous oxygen pressure
时间窗: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
Change in transcutaneous oxygen pressure is measured before and after the revascularization procedure.
次要结局
- Secondary patency(Post-procedural (within 5 days) and 3 months after the index procedure)
- Fluorescence angiography(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)
- Survival(Post-procedural (within 5 days) and 3 months after the index procedure)
- Primary patency(Post-procedural (within 5 days) and 3 months after the index procedure)
- Ankle-brachial index (ABI)(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)
- Rutherford category(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)
- Limb salvage(Post-procedural (within 5 days) and 3 months after the index procedure)
- WIfI stage(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)