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NCT Number: NCT07816757

Clinical Value of CT Perfusion in Peripheral Artery Disease

Peripheral artery disease (PAD) affects millions worldwide and can lead to serious complications such as leg ulcers, gangrene, and amputation. Current imaging methods mainly evaluate large blood vessels but do not measure microcirculation in the foot. Computed tomography perfusion (CTP) is a new technique that can assess blood flow in small vessels.

The purpose of this study is to see whether combining CTP measurements with standard CT angiography images and patient clinical information can help predict which PAD patients are more likely to have poor outcomes after surgery to restore blood flow (revascularization). Poor outcomes include death or major limb problems such as amputation or need for another procedure.

This is an observational study. Researchers will collect data from about 200 adult PAD patients who are scheduled to undergo revascularization. Participants will receive routine care including CT scans before and after surgery. No experimental drugs or devices are given. Researchers will follow participants for up to 2 years after surgery through medical records and phone calls to track their recovery and any complications.

The results may help doctors identify high-risk patients earlier and improve treatment decisions.

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Key information

Conditions

Peripheral Artery Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis CT Perfusion Cardiovascular Diseases Microcirculation Peripheral Arterial Disease Peripheral Vascular Diseases Prognosis Revascularization Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of peripheral artery disease (PAD) confirmed by clinical evaluation and imaging (e.g., CTA, DSA).
  • Planned to undergo endovascular or surgical revascularization.
  • Age ≥ 18 years old.
  • Signed written informed consent.

Exclusion criteria

  • Allergy to iodinated contrast agents.
  • Severe renal insufficiency (e.g., eGFR < 30 mL/min/1.73m²).
  • Acute limb ischemia requiring emergency surgery.
  • Major limb amputation already performed prior to enrollment.
  • Life expectancy less than 2 years due to severe comorbidities.
  • Unwilling or unable to complete the 2-year follow-up.

Treatment and study plan

Primary outcomes

  1. Predictive value of CT perfusion for adverse clinical events after revascularization

    Time frame: From baseline (preoperative) assessment through 2 years after revascularization

    Assessment of the predictive value of computed tomography perfusion (CTP) parameters combined with CT angiography and clinical data for postoperative adverse outcomes. Adverse clinical events are defined as all-cause mortality, major adverse limb events (including major amputation and target limb reintervention), or non-healing ulcers/gangrene. Data will be collected through medical records and follow-up visits.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Acronym: iPAD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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