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NOT YET RECRUITING
NCT06619223

Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

121

Start Date

2024-10-10

Completion Date

2026-06-30

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Duplex Ultrasound

The primary intervention in this study is the use of ankle Doppler waveform assessment for post-revascularisation surveillance in patients with Peripheral Arterial Disease (PAD). This technique utilises continuous-wave Doppler (CWD) and pulsed-wave Doppler (PWD) to assess the blood flow in the key ankle arteries, including the dorsalis pedis artery (DPA) and posterior tibial artery (PTA).