Peripheral Artery Disease (PAD)ROPNCT07602634
Radiomics Features Predicting Outcomes of PAD
An observational study of Peripheral Artery Disease (PAD), run by Zhijun Bao at 1 site in China.
Trial summary
There is a high risk of restenosis and vascular occlusion after interventional treatment for peripheral arterial disease (PAD), and some severe patients inevitably end up with amputation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- What is being tested?
- Non interventional study
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of peripheral artery disease after intervention
Who may be able to join
- aged between 18 and 100 years;
- meeting the diagnostic criteria for peripheral artery disease (PAD);
- successfully undergoing interventional surgery;
- successfully completing preoperative lower limb CTA or MRA examination with good image quality, suitable for radiomics analysis.
Who cannot join
- Heart failure (NYHA class III/IV);
- right-to-left shunt heart disease;
- severe aortic and mitral valve insufficiency;
- acute coronary syndrome, or malignant arrhythmia;
- severe pulmonary hypertension (pulmonary artery pressure >90mmHg);
- moderate to severe renal insufficiency (creatinine clearance rate <60ml/min);
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- any allergic constitution;
- pregnancy and childbirth period;
- life expectancy <12 months;
- poor image quality, unable to analyze;
- incomplete medical history data;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiomics Features for Predicting Clinical Outcomes in Peripheral Artery Disease
There is a high risk of restenosis and vascular occlusion after interventional treatment for peripheral arterial disease (PAD), and some severe patients inevitably end up with amputation. Perivascular adipose tissue (PVAT) has been recognized not only as an inert tissue providing mechanical support, but also as a highly active endocrine and paracrine organ, which could provide a new imaging perspective into the pathophysiological mechanism of lower limb atherosclerosis microenvironment. The aim of this study is to identify novel and reliable non-invasive imaging biomarkers by exploring the potential association between lower limb PVAT imaging omics features and clinical outcomes (including death, major amputation, target vessel revascularization, etc.) in patients with PAD after interventional treatment. The study aims to offer clinicians with more accurate personalized risk stratification tools before surgery, thereby optimizing clinical decision-making and helping to achieve precision medicine for PAD.
Read the detailed description
After interventional treatment for peripheral arterial disease (PAD), there is a high risk of restenosis and vascular occlusion, and some severe patients inevitably end up with amputation. Currently, in clinical practice, preoperative CTA is often relied upon to assess the degree of luminal stenosis and wall calcification burden in order to develop surgical strategies and predict prognosis. However, these traditional macroscopic indicators often cannot fully reflect the microscopic inflammatory state of the vascular wall and plaque instability, resulting in limited predictive power for postoperative clinical outcomes.
In recent years, perivascular adipose tissue (PVAT) has been recognized not only as an inert tissue providing mechanical support, but also as a highly active endocrine and paracrine organ. In the early stage of atherosclerosis, the inflammatory signal of vascular wall can be transmitted from the inside out to PVAT, causing changes in its phenotype and local lipid metabolism. At present, breakthrough progress has been made in imaging research on PVAT both domestically and internationally, but the vast majority of studies focus on coronary arteries, carotid arteries, and aorta. For example, based on the conventional coronary CTA extraction of the Pericoronal Fat Attenuation Index (FAI) and radiomics features, it has been proven by multiple high-quality studies to effectively identify vulnerable plaques and independently predict adverse cardiovascular events. However, imaging research on peripheral arterial PVAT in the lower limbs is still in a blank state both domestically and internationally. There are significant differences in hemodynamics, anatomical structure, and risk factors between lower limb arteries and coronary and carotid arteries. It is urgent to explore whether the imaging phenotype changes of lower limb PVAT can also serve as a detector for evaluating local vascular lesions.
This project is the first to shift the focus to the peripheral arteries of the lower limbs. By introducing high-throughput radiomics techniques, non-invasive and quantitative extraction of three-dimensional spatial texture and grayscale heterogeneity features of lower limb PVAT that cannot be recognized by the naked eye is performed from routine preoperative lower limb vascular enhancement images (CTA or MRA) of patients. This not only expands the disease research spectrum of PVAT, but also provides a new imaging perspective for in-depth understanding of the pathophysiological mechanism of lower limb atherosclerosis microenvironment.
This study is based on real clinical application scenarios and does not require patients to bear additional radiation risks or examination costs. The aim of this project is to identify novel and reliable non-invasive imaging biomarkers by exploring the potential association between lower limb PVAT imaging omics features and clinical outcomes (including death, major amputation, target vessel revascularization, etc.) in patients with PAD after intracavitary treatment. This is expected to break the limitations of traditional lumen stenosis and calcification assessment, providing clinicians with more accurate personalized risk stratification tools before surgery, thereby optimizing clinical decision-making and helping to achieve precision medicine for PAD.
- Conditions
- Peripheral Artery Disease (PAD)
- Being tested
- Non interventional study
- 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.
Non interventional studyOther
non
| Study group | Role | What they receive |
|---|---|---|
| patients of peripheral artery disease | patients of peripheral artery disease after intervention Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse limb events
severe adverse clinical events occurring in the limbs, such as target-limb re-intervention, acute limb ischemia, amputation, etc.
Measured: From January 2015 to December 2025
Secondary outcomes (2)
all-cause death
death caused by any event
Measured: From January 2015 to December 2025
Major adverse cardiovascular events
severe cardiovascular-related adverse events, typically including myocardial infarction (heart attack), stroke, cardiovascular death, etc,
Measured: From January 2015 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhijun Bao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhijun Bao, Fudan University
- Investigators
- Jun Zhi Bao, Hospital Director, Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602634
- Sponsor's protocol ID
- 2026K201
- Other IDs
- 20260049
- Acronym
- ROP
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics Features for Predicting Clinical Outcomes in Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07602634
- Acronym / sponsor ID
- ROP / 2026K201
- Conditions
- Peripheral Artery Disease (PAD)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhijun BaoUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (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.
There is a high risk of restenosis and vascular occlusion after interventional treatment for peripheral arterial disease (PAD), and some severe patients inevitably end up with amputation. Perivascular adipose tissue (PVAT) has been recognized not only as an inert tissue providing mechanical support, but also as a highly active endocrine and paracrine organ, which could provide a new imaging perspective into the pathophysiological mechanism of lower limb atherosclerosis microenvironment. The aim of this study is to identify novel and reliable non-invasive imaging biomarkers by exploring the potential association between lower limb PVAT imaging omics features and clinical outcomes (including death, major amputation, target vessel revascularization, etc.) in patients with PAD after interventional treatment. The study aims to offer clinicians with more accurate personalized risk stratification tools before surgery, thereby optimizing clinical decision-making and helping to achieve precision medicine for PAD.
Detailed description
After interventional treatment for peripheral arterial disease (PAD), there is a high risk of restenosis and vascular occlusion, and some severe patients inevitably end up with amputation. Currently, in clinical practice, preoperative CTA is often relied upon to assess the degree of luminal stenosis and wall calcification burden in order to develop surgical strategies and predict prognosis. However, these traditional macroscopic indicators often cannot fully reflect the microscopic inflammatory state of the vascular wall and plaque instability, resulting in limited predictive power for postoperative clinical outcomes.
In recent years, perivascular adipose tissue (PVAT) has been recognized not only as an inert tissue providing mechanical support, but also as a highly active endocrine and paracrine organ. In the early stage of atherosclerosis, the inflammatory signal of vascular wall can be transmitted from the inside out to PVAT, causing changes in its phenotype and local lipid metabolism. At present, breakthrough progress has been made in imaging research on PVAT both domestically and internationally, but the vast majority of studies focus on coronary arteries, carotid arteries, and aorta. For example, based on the conventional coronary CTA extraction of the Pericoronal Fat Attenuation Index (FAI) and radiomics features, it has been proven by multiple high-quality studies to effectively identify vulnerable plaques and independently predict adverse cardiovascular events. However, imaging research on peripheral arterial PVAT in the lower limbs is still in a blank state both domestically and internationally. There are significant differences in hemodynamics, anatomical structure, and risk factors between lower limb arteries and coronary and carotid arteries. It is urgent to explore whether the imaging phenotype changes of lower limb PVAT can also serve as a detector for evaluating local vascular lesions.
This project is the first to shift the focus to the peripheral arteries of the lower limbs. By introducing high-throughput radiomics techniques, non-invasive and quantitative extraction of three-dimensional spatial texture and grayscale heterogeneity features of lower limb PVAT that cannot be recognized by the naked eye is performed from routine preoperative lower limb vascular enhancement images (CTA or MRA) of patients. This not only expands the disease research spectrum of PVAT, but also provides a new imaging perspective for in-depth understanding of the pathophysiological mechanism of lower limb atherosclerosis microenvironment.
This study is based on real clinical application scenarios and does not require patients to bear additional radiation risks or examination costs. The aim of this project is to identify novel and reliable non-invasive imaging biomarkers by exploring the potential association between lower limb PVAT imaging omics features and clinical outcomes (including death, major amputation, target vessel revascularization, etc.) in patients with PAD after intracavitary treatment. This is expected to break the limitations of traditional lumen stenosis and calcification assessment, providing clinicians with more accurate personalized risk stratification tools before surgery, thereby optimizing clinical decision-making and helping to achieve precision medicine for PAD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients of peripheral artery disease | – | Other: Non interventional studypatients of peripheral artery disease after intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of peripheral artery disease after intervention
Key inclusion criteria (4 listed)
- aged between 18 and 100 years;
- meeting the diagnostic criteria for peripheral artery disease (PAD);
- successfully undergoing interventional surgery;
- successfully completing preoperative lower limb CTA or MRA examination with good image quality, suitable for radiomics analysis.
Key exclusion criteria (11 listed)
- Heart failure (NYHA class III/IV);
- right-to-left shunt heart disease;
- severe aortic and mitral valve insufficiency;
- acute coronary syndrome, or malignant arrhythmia;
- severe pulmonary hypertension (pulmonary artery pressure >90mmHg);
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 |
|---|---|---|
| Non interventional studynon | Other | patients of peripheral artery disease |
Primary outcome
major adverse limb events
Time frame: From January 2015 to December 2025
severe adverse clinical events occurring in the limbs, such as target-limb re-intervention, acute limb ischemia, amputation, etc.
2 secondary outcomes
all-cause death
Time frame: From January 2015 to December 2025
Major adverse cardiovascular events
Time frame: From January 2015 to December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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The THOR IDE Study
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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.
Jun Zhi Bao, Hospital Director study director
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease (PAD), run by Zhijun Bao at 1 site in China.
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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse limb events (time frame: From January 2015 to December 2025). 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 22 May 2026.