Clinical Value of CT Perfusion in Peripheral Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
This study will enroll adult patients diagnosed with peripheral artery disease (PAD) who are scheduled to undergo vascular reconstruction (endovascular or surgical). Participants will receive CT perfusion imaging prior to the procedure. The study population aims to investigate the predictive value of CT perfusion parameters for postoperative adverse clinical events, with a planned follow-up period of 2 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Predictive value of CT perfusion for adverse clinical events 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.
Time frame
From baseline (preoperative) assessment through 2 years after revascularizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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