Radiomics Features Predicting Outcomes of PAD

NCT07602634 | Active Not Recruiting DMC

• 2 other identifiers: 2026K20120260049
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Peripheral Artery Disease (PAD)

Outcome Measures

Primary Outcomes (1)

• major adverse limb events

  severe adverse clinical events occurring in the limbs, such as target-limb re-intervention, acute limb ischemia, amputation, etc.

  From January 2015 to December 2025

Secondary Outcomes (2)

• all-cause death

  From January 2015 to December 2025

• Major adverse cardiovascular events

  From January 2015 to December 2025

Study Arms (1)

patients of peripheral artery disease

patients of peripheral artery disease after intervention

Other: Non interventional study

Interventions

Non interventional study OTHER

non

patients of peripheral artery disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients of peripheral artery disease after intervention

You may qualify if:

• 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.

You may not qualify if:

• 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);
• any allergic constitution;
• pregnancy and childbirth period;
• life expectancy \<12 months;
• poor image quality, unable to analyze;
• incomplete medical history data;

Sponsors & Collaborators

• Zhijun Bao: lead

Study Sites (1)

Huadong Hospital

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Jun Zhi Bao, Hospital Director

  Huadong Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hospital Director

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)