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Trial registered on ANZCTR
Registration number
ACTRN12625000889459p
Ethics application status
Submitted, not yet approved
Date submitted
15/07/2025
Date registered
15/08/2025
Date last updated
15/08/2025
Date data sharing statement initially provided
15/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Duplex Ultrasound Surveillance After Endovascular Therapy for Peripheral Arterial Disease - Randomized Controlled Trial (SURVEIL)
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Scientific title
The Efficacy of Duplex Ultrasound Surveillance after Endovascular Therapy for Preventing Complications of Peripheral Arterial Disease - Randomized Controlled Trial (SURVEIL)
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Secondary ID [1]
314911
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
338227
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Condition category
Condition code
Cardiovascular
334504
334504
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
331516
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Early detection / Screening
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Comparator / control treatment
Clinical Surveillance Group (Comparator):
Participants will receive systematic clinical surveillance (comprehensive history, physical examination, and ankle-brachial pressure index measurement) by a vascular surgeon in the outpatient setting without routine duplex ultrasound scanning. Additional investigations may be ordered at clinical discretion based on symptom development, clinical deterioration, or significant changes in ankle-brachial pressure indices. Each surveillance review (including clinical and ABI) will take up to 45 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.
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Control group
Active
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Outcomes
Primary outcome [1]
342189
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Composite outcome of peripheral arterial disease complications including any of the following: 1) Target Vessel Occlusion 2) Major Adverse Limb Event (above-ankle amputation, new bypass, interposition graft revision, open thrombectomy or thrombolysis) 3) Death
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Assessment method [1]
342189
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1. Target Vessel Occlusion: Complete occlusion identified on duplex ultrasound at any time during study 2. Major Adverse Limb Event: Above-ankle amputation or major index-limb re-intervention (new bypass, interposition graft revision, open thrombectomy or thrombolysis) to be reported on assessment by clinician and self-reported by participant. Clinician may access participants' medical records. 3. Death: Any cause of post-operative death. Determined by confirmation by proxies (i.e. family/friends) and medical records.
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Timepoint [1]
342189
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Baseline (4-6 weeks post index procedure), 3-, 6-, 9-, 12-, 18- and 24-months post index-procedure. The primary endpoint is a time-to-event outcome assessed continuously over 24 months. The primary endpoint is a time-to-event outcome assessed continuously over 24 months.
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Secondary outcome [1]
449859
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Target Lesion Revascularization
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Assessment method [1]
449859
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Reintervention for the target lesion. To be reported on assessment by clinician and self-reported by participant. Clinician may access participants' medical records.
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Timepoint [1]
449859
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [2]
449860
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Clinically Driven Target Lesion Revascularization (CD-TLR)
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Assessment method [2]
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Clinically-Driven Target Lesion Revascularization is defined as a Target Lesion Revascularization performed due to worsening or recurrent symptoms of ischemia with a target lesion diameter stenosis of greater than or equal to 50% on imaging (DUS or DSA) and ABI decrease of greater than or equal to 0.1. To be reported on assessment by clinician and self-reported by participant. Clinician may access participants' medical records.
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Timepoint [2]
449860
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [3]
449861
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Minor Reinterventions on the Index Femoropopliteal Segment
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Assessment method [3]
449861
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Endovascular reintervention excluding thrombectomy or thrombolysis. To be reported on assessment by clinician and self-reported by participant. Clinician may access participants' medical records.
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Timepoint [3]
449861
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [4]
449862
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Minor Reinterventions on the Index Limb, not on the Femoropopliteal Segment
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Assessment method [4]
449862
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Endovascular reintervention excluding thrombectomy or thrombolysis. To be reported on assessment by clinician and self-reported by participant. Clinician may access participants' medical records.
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Timepoint [4]
449862
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [5]
449863
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Major Adverse Cardiac Event (MACE)
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Assessment method [5]
449863
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Myocardial infarction, transient ischemic attack, or stroke. To be reported on assessment by clinician and self-reported by participant. Clinician may access participants' medical records.
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Timepoint [5]
449863
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [6]
449864
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Restenosis
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Assessment method [6]
449864
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Primary moderate restenosis (50-74% luminal narrowing) diagnosed with PSVR greater than or equal to 2 on duplex ultrasound Primary severe restenosis (greater than or equal to 75% luminal narrowing) diagnosed with PSVR greater than or equal to 4 on duplex ultrasound
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Timepoint [6]
449864
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [7]
449865
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Target Vessel Primary Patency
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Assessment method [7]
449865
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Primary patency is defined as unassisted patency (absence of 100% target vessel occlusion) at 24-months post-index procedure. As identified from imaging evidence of occlusion (including outpatient sonography or available medical records).
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Timepoint [7]
449865
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Baseline (4-6 weeks post index procedure) and 24-months post index procedure.
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Secondary outcome [8]
449866
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Symptomatic Status
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Assessment method [8]
449866
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By Rutherford-Becker category
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Timepoint [8]
449866
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Baseline (4-6 weeks post index procedure), 3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [9]
449867
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Index Wound Healing
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Assessment method [9]
449867
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Index wound healing assessed by Wound Ischaemia and Foot Infection (WIFI). The WIFI score assesses three key domains in patients with diabetic foot ulcers or chronic limb-threatening ischeamia. Wound assessment evaluates ulcer characteristics: grade 0 (no ulcer), grade 1 (small shallow ulcer), grade 2 (deeper ulcer reaching tendon/bone), or grade 3 (extensive deep ulcer with bone/joint involvement). Ischemia assessment measures perfusion using ankle-brachial index, toe pressure, or transcutaneous oxygen pressure: grade 0 (no ischemia with ABI less than 0.80), grade 1 (mild ischemia with ABI 0.60 to 0.79), grade 2 (moderate ischemia with ABI 0.40 to 0.59), or grade 3 (severe ischemia with ABI less than 0.40). Foot infection assessment evaluates clinical signs: grade 0 (no infection), grade 1 (mild infection with less than 2cm cellulitis), grade 2 (moderate infection with greater than 2cm cellulitis or deeper tissue involvement), or grade 3 (severe infection with systemic toxicity or extensive tissue necrosis). Each domain receives a score of 0 to 3, and the combined WIFI score predicts clinical outcomes including amputation risk and healing potential.
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Timepoint [9]
449867
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3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [10]
449868
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Generic Quality of Life
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Assessment method [10]
449868
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EuroQol 5-Dimension 5-Level questionnaire
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Timepoint [10]
449868
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Baseline (4-6 weeks post index procedure) and 3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [11]
449869
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Cost of Intervention
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Assessment method [11]
449869
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Total health resource cost per patient (composite of hospital, primary health care, allied health care, accommodation, support services, equipment, work/productivity and transport costs). Health-Resource Utilization questionnaire to be completed by clinician and participants at 6-monthly clinical review (baseline , 6-, 12-, 18- and 24-months post index intervention).
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Timepoint [11]
449869
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Baseline (4-6 weeks post index procedure), 6-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [12]
449870
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Total No. of Duplexes
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Assessment method [12]
449870
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Number of duplex ultrasounds performed for target vessel. Surgeon-reported.
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Timepoint [12]
449870
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24-months post index procedure.
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Secondary outcome [13]
449871
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Cost-effectiveness outcomes
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Assessment method [13]
449871
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• Total healthcare costs per patient (as outlined Total Health Resource cost per patient, a composite of hospital, primary health care, allied health care, accommodation, support services, equipment, work/productivity and transport costs). Health-Resource Utilization questionnaire to be completed by clinician and participants at 6-monthly clinical review (baseline, 6-, 12-, 18- and 24-months post index intervention). • Quality-adjusted life years (QALYs) • Incremental cost-effectiveness ratio (ICER) • Cost per composite endpoint avoided
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Timepoint [13]
449871
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24-months post index procedure.
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Secondary outcome [14]
450189
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Target Vessel Primary-Assisted Patency
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Assessment method [14]
450189
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Primary-assisted patency is defined as patent (absence of 100% target vessel occlusion) at 24-months post-index procedure, with one or more reinterventions without any incidence of complete target vessel occlusion. As identified from imaging evidence of occlusion (including outpatient sonography or available medical records).
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Timepoint [14]
450189
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at 24-months post index procedure
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Secondary outcome [15]
450190
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Target Vessel Secondary Patency
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Assessment method [15]
450190
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Secondary patency is defined as patent (absence of 100% target vessel occlusion) at 24-months post-index procedure after at least one episode of complete target vessel occlusion. As identified from imaging evidence of occlusion (including outpatient sonography or available medical records).
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Timepoint [15]
450190
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at 24-months post index procedure
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Secondary outcome [16]
450191
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Disease-specific Quality of Life
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Assessment method [16]
450191
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VascuQol Questionnaire
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Timepoint [16]
450191
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Baseline (4-6 weeks post index procedure) and 3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Secondary outcome [17]
450715
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Quality of life - Generic (SF-12)
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Assessment method [17]
450715
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Short Form-12 Health Survey questionnaire
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Timepoint [17]
450715
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Baseline (4-6 weeks post index procedure) and 3-, 6-, 9-, 12-, 18- and 24-months post index-procedure.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software. Stratified by site and presenting symptom (claudication vs chronic limb-threatening ischaemia)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2026
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Actual
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Date of last participant enrolment
Anticipated
30/06/2027
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Actual
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Date of last data collection
Anticipated
30/06/2029
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Actual
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Sample size
Target
288
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
27232
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New Zealand
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State/province [1]
27232
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Funding & Sponsors
Funding source category [1]
319476
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Hospital
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Name [1]
319476
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Prince of Wales Vascular Institute
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Address [1]
319476
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Country [1]
319476
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Australia
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Primary sponsor type
Government body
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Name
South Eastern Sydney Local Health District
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Address
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Country
Australia
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Secondary sponsor category [1]
321965
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None
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Name [1]
321965
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none
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Address [1]
321965
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Country [1]
321965
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
318046
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South Eastern Sydney Local Health District HREC
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Ethics committee address [1]
318046
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https://www.seslhd.health.nsw.gov.au/services-clinics/directory/research-home/ethics
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Ethics committee country [1]
318046
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Australia
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Date submitted for ethics approval [1]
318046
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22/05/2025
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Approval date [1]
318046
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Ethics approval number [1]
318046
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Thomas Warburton
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Address
142950
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Suite 8, Level 7, Prince of Wales Private Hospital, Barker Street, Randwick, NSW, 2031
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Country
142950
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Australia
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Phone
142950
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+61 421872464
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Fax
142950
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Email
142950
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[email protected]
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Contact person for public queries
Name
142951
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Thomas Warburton
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Address
142951
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Suite 8, Level 7, Prince of Wales Private Hospital, Barker Street, Randwick, NSW, 2031
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Country
142951
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Australia
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Phone
142951
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+61 421872464
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Fax
142951
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Email
142951
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[email protected]
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Contact person for scientific queries
Name
142952
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Thomas Warburton
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Address
142952
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Suite 8, Level 7, Prince of Wales Private Hospital, Barker Street, Randwick, NSW, 2031
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Country
142952
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Australia
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Phone
142952
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+61 421872464
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Fax
142952
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Email
142952
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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