Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 121
- 主要终点
- Sensitivity of Ankle Doppler Waveform Assessment for Detecting Arterial Restenosis
研究概览
简要总结
The goal of this observational study is to determine the diagnostic performance of serial ankle arterial Doppler waveform assessments in detecting significant arterial restenosis in patients with Peripheral Arterial Disease (PAD) undergoing lower limb revascularization. The main questions it aims to answer are:
Can serial ankle Doppler waveform assessments accurately detect restenosis following revascularization? How cost-effective is this method for long-term patient surveillance? Researchers will compare the results of serial visual Doppler waveform assessments (handheld continuous-wave and pulsed-wave Doppler) with full lower limb arterial duplex ultrasound (DUS) to determine if the Doppler devices provide a comparable diagnostic performance.
Participants will:
Undergo regular pre- and post-revascularization ankle waveform assessments. Participate in follow-up surveillance visits at 3, 6, and 12 months.
详细描述
This study is a single-centre, prospective observational diagnostic accuracy study designed to evaluate the effectiveness of serial ankle arterial Doppler waveform assessments for post-revascularisation surveillance in patients with Peripheral Arterial Disease (PAD). The study will compare Doppler waveform assessments using both handheld continuous-wave Doppler and pulsed-wave duplex ultrasound (PWD) against a full lower limb duplex ultrasound (DUS), which serves as the reference standard.
Study Procedures:
The study involves a series of non-invasive, repeatable tests that monitor blood flow in the ankle arteries. The following arteries will be examined at the ankle:
Dorsalis pedis artery (DPA) Posterior tibial artery (PTA)
Waveforms are captured and analysed using both auditory and visual outputs from the Doppler devices. Pathological findings, such as monophasic waveforms (indicative of restenosis), will be compared to the normal biphasic or triphasic waveforms.
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
- •Adult patients (aged 18 and above) with diagnosed Peripheral Arterial Disease (PAD).
- •Patients scheduled for lower limb revascularisation procedures.
- •Patients willing and able to provide informed consent.
- •Patients who can attend follow-up visits at 3, 6, and 12 months post-revascularisation.
排除标准
- •Patients with non-compressible arteries (due to calcification or other reasons).
- •Patients who are unable to undergo Doppler assessments for any reason.
结局指标
主要结局
Sensitivity of Ankle Doppler Waveform Assessment for Detecting Arterial Restenosis
时间窗: 12 months post-revascularisation
The primary outcome is the diagnostic sensitivity of serial ankle Doppler waveform assessments (using continuous-wave and pulsed-wave Doppler) for detecting significant arterial restenosis in the dorsalis pedis artery and posterior tibial artery. The sensitivity of the Doppler waveform results will be compared against the reference standard of a full lower limb duplex ultrasound (DUS), performed at baseline and during follow-up surveillance visits post-revascularisation.
次要结局
- Specificity and Predictive Values of Ankle Doppler Waveform for Arterial Restenosis(12 months post-revascularisation)
- Cost-Effectiveness of Ankle Doppler Waveform Assessment(5 years)