None listed
Conditions
Brief summary
Peripheral arterial disease management costs AUD $884 million per year. Post-operative duplex ultrasound surveillance is commonly used, despite limited evidence, based on theoretical benefits. International guidelines explicitly highlight this as a priority research area. This RCT is proposed to definitively evaluate whether ultrasound surveillance provides clinical benefits (preventing vessel occlusion, major adverse limb events or death) following femoropopliteal endovascular intervention compared to clinical surveillance alone. Both surveillance and peripheral arterial disease are costly, and the opportunity to identify cost-effectiveness is significant. This landmark study will provide urgently needed evidence to guide clinical practice, improve patient outcomes, and ensure cost-effective health-resource use.
Interventions
Duplex Ultrasound Surveillance (Intervention):
Participants will receive systematic clinical surveillance (comprehensive history, physical examination, and ankle-brachial pressure index measurement) by a vascular surgeon in the outpatient setting with adjunctive duplex ultrasound scanning performed by a sonographer. Imaging results will be available to treating clinicians at the time of consultation to inform clinical decision-making. Each surveillance review (including clinical review, ABI and
Duplex Ultrasound Surveillance (Intervention): Participants will receive systematic clinical surveillance (comprehensive history, physical examination, and ankle-brachial pressure index measurement) by a vascular surgeon in the outpatient setting with adjunctive duplex ultrasound scanning performed by a sonographer. Imaging results will be available to treating clinicians at the time of consultation to inform clinical decision-making. Each surveillance review (including clinical review, ABI and duplex ultrasound scan) will take up to 90 minutes. Session attendance and completion will be recorded on routine case report form. This assessment is currently considered within the accepted standard of care. To be performed at 3, 6, 9, 12, 18 and 24 months post-index-intervention.
Sponsors
South Eastern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be over 18 years of age 2. Must have undergone endovascular intervention of the superficial femoral artery and/or ipsilateral popliteal artery for symptomatic peripheral arterial disease. 3. Target vessel must be patent at 4-6 weeks after operation, to exclude cases with acute technical failure from the trial. Patency defined as absence of a >75% stenosis on duplex at 4-6 weeks. 4. Must have adequate femoropopliteal inflow, defined as a triphasic waveform in the common femoral artery at time of enrolment. 5. Must have adequate tibial outflow, defined by at least a single patent tibial vessel to the ankle at time of enrolment 6. Must be able to give informed consent 7. Must have a life expectancy of at least 6 months
Exclusion criteria
1. Participants participating in another clinical study 2. Participants that are not compliant with routine follow-up 3. Participants with previous above ankle amputation of the index limb 4. Participants with disease or other factor that would otherwise necessitate surveillance and prevent equipoise in the delivery of postoperative clinical vs duplex ultrasound surveillance
Outcome results
None listed