Clinical Value of CT Perfusion in Peripheral Artery Disease (iPAD)
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.
Descripción general del estudio
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Tipo de estudio
Inscripción (Estimado)
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Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
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Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
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Predictive value of CT perfusion for adverse clinical events after revascularization
Periodo de tiempo: From baseline (preoperative) assessment through 2 years after revascularization
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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.
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From baseline (preoperative) assessment through 2 years after revascularization
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Colaboradores e Investigadores
Patrocinador
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Términos relacionados con este estudio
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Otros números de identificación del estudio
- 2026K
Información sobre medicamentos y dispositivos, documentos del estudio
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