Peripheral Arterial DiseaseCTS-PADNCT05243992
Clinical Testing Study in Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by Perfusio Corp..
Trial summary
The Purpose of the Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD) study is to compare measurement outcomes between conventional Ankle-Brachial Index test for Peripheral Arterial Disease with a new imaging technology from which the same data can be derived, in a series of patients referred to Vascular… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- CTS-PAD device imaging
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population: The screening population for this study will be adults seen in vascular clinic referred for peripheral arterial disease. The U of R Vascular Clinic performs > 40-50 cABI studies / month, and their clinic population has patients with severe PVD at presentation, extensive cardiovascular risk factors that affect the sensitivity of cABI testing, and heterogenous age, race and gender characteristics. An analysis of the patient population demographics suggests that the gender distribution will be 60% male and 40% female in this study. Gender-based enrollment restrictions include women who are pregnant or who might be pregnant, since the imaging technology has not been tested in this sub-population. There are no enrollment restrictions based on race and/or ethnic origin. Overall enrollment is anticipated to be 60% Caucasian, 20% African-American, 6% Hispanic, non-white, 1% Asian, and 1% Other.
Who may be able to join
- patients who meet the clinical, symptomatic and or the disease complexity criteria for cABI testing
- age > 21 years
- intact bilateral upper and lower extremities
Who cannot join
- patients who are not considered candidates for the cABI test
- patients < 21 years
- women who might be pregnant or who are pregnant
- patients who are not considered eligible by the Attending Vascular Surgical team in clinic for medical reasons
- patients who are unable to undergo the cABI study
- patients who are unable to complete the precedent cABI study
Show all 9Show fewer
- patients without intact bilateral upper and lower extremities
- patients with lower extremity edema or associated vascular disease where performance of the precedent cABI test would be difficult or unlikely to yield reliable data
- asymptomatic patients without complex disease characteristics, since they would not be referred for cABI testing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD)
The Purpose of the Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD) study is to compare measurement outcomes between conventional Ankle-Brachial Index test for Peripheral Arterial Disease with a new imaging technology from which the same data can be derived, in a series of patients referred to Vascular Surgery Clinics at the University of Rochester for suspected peripheral arterial disease.
Read the detailed description
Peripheral arterial disease (PAD) is a subset of peripheral vascular disease, which describes a spectrum of perfusion- and metabolism-related threats to the tissues of the lower extremities. PAD affects an estimated 8.5 million adults in the US and > 200 million adults worldwide. PAD is atherosclerosis in the lower limbs, and classically results in inadequate oxygen supply to lower extremity musculature during walking. However, PAD is often asymptomatic, or symptoms are atypical. Risk factors are similar to cardiovascular and cerebrovascular diseases: smoking, diabetes, older age, high blood pressure, and high cholesterol.
The initial diagnostic evaluation step in symptomatic patients (i.e., classic claudication) with PAD is the conventional Ankle-Brachial Index (cABI) test. In symptomatic patients, an ABI < 0.90 (normal range 0.91-1.3) is approximately 72% sensitive and 99% specific for angiographically significant (> 50% stenosis) PAD. However, co-morbid diseases and asymptomatic/atypical patient characteristics adversely impact this test performance. In diabetics, this sensitivity falls to < 50%. Therefore, adequate strategies for screening asymptomatic/atypical patients presenting for PAD evaluation is an unmet healthcare need.
This Small Business Technology Transfer (STTR) Phase II observational study (CTS-PAD) objective is to test a novel technologic solution to address this need. Since cABI is a single factor test (< 0.9 = > 50% stenosis), it must be broadened to collect additional data that will increase the test specificity in this PAD sub-population. In parallel to stable ischemic heart disease and the importance of functional stenoses and myocardial microperfusion, these additional data should address end-organ tissue physiology as perfused by the atherosclerotic arterial supply. The asymptomatic patients' co-morbidities affect the tissue microvascularity (i.e., diabetes), and oxygen delivery and perfusion (i.e., smoking).
Perfusio Corp.'s Multi-spectral Physiologic Visualization (MSPV) imaging technology, now FDA-approved, is the base platform for this new approach, which in addition to dynamic perfusion analytics incorporates peripheral oxygen saturation (SpO2) and cardiovascular Vital Signs of Heart Rate (HR) and Blood Pressure (BP), all in immediate real-time. This CTS-PAD observational study device is non-invasive and non-contact.
The Hypothesis of the study is that ABI-type blood pressure ratio data and these tissue- and perfusion-related factors can be captured and integrated in real-time, to improve the sensitivity of evaluation in this PAD subset. The Objective of the CTS-PAD study is to document clinical Proof of Concept for this novel approach and device.
The CTS-PAD study is designed to simply collect these data for off-line, post-hoc analyses. The data from the CTS-PAD device will not be used for any clinical decision-making, and as such the clinical team will be blinded from the CTS-PAD device results data.
- Conditions
- Peripheral Arterial Disease
- Being tested
- CTS-PAD device imaging
- Keywords
- tissue perfusion, tissue hypoxemia
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTS-PAD device imagingOther
Participants in the CTS-PAD Study will undergo a conventional ABI (cABI) evaluation, followed by the non-contact imaging evaluation with the CTS-PAD device. The supplemental CTS-PAD testing will add approximately ten (10) minutes to the overall evaluation time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio Comparison
Comparison of the cABI systolic BP threshold ratio vs. the CTS-PAD perfusion ratio
Measured: ten (10) minutes
Secondary outcomes (2)
Clinical status impact on CTS-PAD outcomes
correlate clinical status with CTS-PAD perfusion and physiologic data (SpO2, VS data)
Measured: ten (10) minutes
Device use and performance
Evaluate device performance and patient and provider acceptance of this approach
Measured: ten (10) minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perfusio Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Thomas B Ferguson, MD, Study director, Perfusio Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243992
- Sponsor's protocol ID
- CTS-PAD 0133633 Ver00004.5
- Acronym
- CTS-PAD
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data are coded, and all analyses will be from aggregate data in the study de-identified database.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD)
- ClinicalTrials.gov ID
- NCT05243992
- Acronym / sponsor ID
- CTS-PAD / CTS-PAD 0133633 Ver00004.5
- Conditions
- Peripheral Arterial Disease
- Keywords
- tissue perfusion, tissue hypoxemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Perfusio Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of the Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD) study is to compare measurement outcomes between conventional Ankle-Brachial Index test for Peripheral Arterial Disease with a new imaging technology from which the same data can be derived, in a series of patients referred to Vascular Surgery Clinics at the University of Rochester for suspected peripheral arterial disease.
Detailed description
Peripheral arterial disease (PAD) is a subset of peripheral vascular disease, which describes a spectrum of perfusion- and metabolism-related threats to the tissues of the lower extremities. PAD affects an estimated 8.5 million adults in the US and > 200 million adults worldwide. PAD is atherosclerosis in the lower limbs, and classically results in inadequate oxygen supply to lower extremity musculature during walking. However, PAD is often asymptomatic, or symptoms are atypical. Risk factors are similar to cardiovascular and cerebrovascular diseases: smoking, diabetes, older age, high blood pressure, and high cholesterol.
The initial diagnostic evaluation step in symptomatic patients (i.e., classic claudication) with PAD is the conventional Ankle-Brachial Index (cABI) test. In symptomatic patients, an ABI < 0.90 (normal range 0.91-1.3) is approximately 72% sensitive and 99% specific for angiographically significant (> 50% stenosis) PAD. However, co-morbid diseases and asymptomatic/atypical patient characteristics adversely impact this test performance. In diabetics, this sensitivity falls to < 50%. Therefore, adequate strategies for screening asymptomatic/atypical patients presenting for PAD evaluation is an unmet healthcare need.
This Small Business Technology Transfer (STTR) Phase II observational study (CTS-PAD) objective is to test a novel technologic solution to address this need. Since cABI is a single factor test (< 0.9 = > 50% stenosis), it must be broadened to collect additional data that will increase the test specificity in this PAD sub-population. In parallel to stable ischemic heart disease and the importance of functional stenoses and myocardial microperfusion, these additional data should address end-organ tissue physiology as perfused by the atherosclerotic arterial supply. The asymptomatic patients' co-morbidities affect the tissue microvascularity (i.e., diabetes), and oxygen delivery and perfusion (i.e., smoking).
Perfusio Corp.'s Multi-spectral Physiologic Visualization (MSPV) imaging technology, now FDA-approved, is the base platform for this new approach, which in addition to dynamic perfusion analytics incorporates peripheral oxygen saturation (SpO2) and cardiovascular Vital Signs of Heart Rate (HR) and Blood Pressure (BP), all in immediate real-time. This CTS-PAD observational study device is non-invasive and non-contact.
The Hypothesis of the study is that ABI-type blood pressure ratio data and these tissue- and perfusion-related factors can be captured and integrated in real-time, to improve the sensitivity of evaluation in this PAD subset. The Objective of the CTS-PAD study is to document clinical Proof of Concept for this novel approach and device.
The CTS-PAD study is designed to simply collect these data for off-line, post-hoc analyses. The data from the CTS-PAD device will not be used for any clinical decision-making, and as such the clinical team will be blinded from the CTS-PAD device results data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population: The screening population for this study will be adults seen in vascular clinic referred for peripheral arterial disease. The U of R Vascular Clinic performs > 40-50 cABI studies / month, and their clinic population has patients with severe PVD at presentation, extensive cardiovascular risk factors that affect the sensitivity of cABI testing, and heterogenous age, race and gender characteristics. An analysis of the patient population demographics suggests that the gender distribution will be 60% male and 40% female in this study. Gender-based enrollment restrictions include women who are pregnant or who might be pregnant, since the imaging technology has not been tested in this sub-population. There are no enrollment restrictions based on race and/or ethnic origin. Overall enrollment is anticipated to be 60% Caucasian, 20% African-American, 6% Hispanic, non-white, 1% Asian, and 1% Other.
Key inclusion criteria (3 listed)
- patients who meet the clinical, symptomatic and or the disease complexity criteria for cABI testing
- age > 21 years
- intact bilateral upper and lower extremities
Key exclusion criteria (9 listed)
- patients who are not considered candidates for the cABI test
- patients < 21 years
- women who might be pregnant or who are pregnant
- patients who are not considered eligible by the Attending Vascular Surgical team in clinic for medical reasons
- patients who are unable to undergo the cABI study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTS-PAD device imagingParticipants in the CTS-PAD Study will undergo a conventional ABI (cABI) evaluation, followed by the non-contact imaging evaluation with the CTS-PAD device. The supplemental CTS-PAD testing will add approximately ten (10) minutes to the overall evaluation time. | Other | – |
Primary outcome
Ratio Comparison
Time frame: ten (10) minutes
Comparison of the cABI systolic BP threshold ratio vs. the CTS-PAD perfusion ratio
2 secondary outcomes
Clinical status impact on CTS-PAD outcomes
Time frame: ten (10) minutes
Device use and performance
Time frame: ten (10) minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Sponsor Web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. All data are coded, and all analyses will be from aggregate data in the study de-identified database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B Ferguson, MD study director
Perfusio Corp.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Perfusio Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas B Ferguson, MD (5044739511, bruce.ferguson@perfusio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio Comparison (time frame: ten (10) minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.