Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619223
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WAVE
Brief 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
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
Detailed Description:
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
Index Tests
Handheld Continuous-Wave Doppler CWD
A continuous signal captures real-time blood flow velocity Visual and audio Doppler signals will be recorded and waveform morphology will be assessed
Waveforms will be stored on an external memory device for later analysis
Pulsed-Wave Doppler PWD Duplex Ultrasound
Provides detailed spectral waveform analysis of ankle vessels using a Doppler angle lt60 to assess the velocity and shape of blood flow
Key parameters such as peak systolic velocity PSV will be measured to detect stenosis
Reference Test
Full Lower Limb Arterial Duplex Ultrasound DUS
Conducted on all patients as part of routine care Measures Peak Systolic Velocity PSV and PSV ratio at areas of suspected stenosis covering the entire lower limb from the iliac to tibial arteries
Data Collection
Data will be collected during pre- and post-revascularisation procedures and participants will undergo follow-up surveillance at 3 6 and 12 months The study will also assess the cost-effectiveness of using ankle Doppler assessments as a substitute for full lower limb DUS with an evaluation of patient acceptability through Likert scale surveys
Reliability Measures
To ensure robustness inter- and intra-rater reliability will be evaluated through repeated tests by the same and different operators Machine learning algorithms will also be applied to classify arterial waveforms based on signal processing techniques
Sample Size and Statistical Analysis
The study will recruit 121 patients with each participant undergoing three surveillance visits post-revascularisation A total of 362 episodes or visits will be analysed Sensitivity specificity and other diagnostic accuracy measures will be calculated with Cohens Kappa used to evaluate agreement between the index and reference tests
The results of this study could provide a cost-effective patient-friendly alternative for post-revascularisation surveillance potentially reducing the need for full DUS exams while maintaining diagnostic accuracy
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
Index Tests
Handheld Continuous-Wave Doppler CWD
A continuous signal captures real-time blood flow velocity Visual and audio Doppler signals will be recorded and waveform morphology will be assessed
Waveforms will be stored on an external memory device for later analysis
Pulsed-Wave Doppler PWD Duplex Ultrasound
Provides detailed spectral waveform analysis of ankle vessels using a Doppler angle lt60 to assess the velocity and shape of blood flow
Key parameters such as peak systolic velocity PSV will be measured to detect stenosis
Reference Test
Full Lower Limb Arterial Duplex Ultrasound DUS
Conducted on all patients as part of routine care Measures Peak Systolic Velocity PSV and PSV ratio at areas of suspected stenosis covering the entire lower limb from the iliac to tibial arteries
Data Collection
Data will be collected during pre- and post-revascularisation procedures and participants will undergo follow-up surveillance at 3 6 and 12 months The study will also assess the cost-effectiveness of using ankle Doppler assessments as a substitute for full lower limb DUS with an evaluation of patient acceptability through Likert scale surveys
Reliability Measures
To ensure robustness inter- and intra-rater reliability will be evaluated through repeated tests by the same and different operators Machine learning algorithms will also be applied to classify arterial waveforms based on signal processing techniques
Sample Size and Statistical Analysis
The study will recruit 121 patients with each participant undergoing three surveillance visits post-revascularisation A total of 362 episodes or visits will be analysed Sensitivity specificity and other diagnostic accuracy measures will be calculated with Cohens Kappa used to evaluate agreement between the index and reference tests
The results of this study could provide a cost-effective patient-friendly alternative for post-revascularisation surveillance potentially reducing the need for full DUS exams while maintaining diagnostic accuracy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None