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OpenTrials
Completed

NCT Number: NCT05575778

Peri-operative Foot CT Perfusion in CLI Patients

To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hua Dong Hospital Affiliated to Fu Dan University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 80 years old;
  • CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
  • Patients completed both pre- and post-operative CTP workups;
  • Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.

Exclusion criteria

  • Patients has participated in other clinical studies;
  • Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min)
  • Any allergic constitution;
  • Pregnancy and childbirth;
  • Life expectancy<12 months.

Treatment and study plan

computed tomographic perfusion

Diagnostic Test

The recruited patients would complete both pre- and post-operative computed tomographic perfusion

Primary outcomes

  1. Pre-operative computed tomographic perfusion parameters

    Time frame: 18months

    Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization.

  2. Post-operative computed tomographic perfusion parameters

    Time frame: 18months

    Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization.

  3. Alteration of computed tomographic perfusion parameters

    Time frame: 18months

    Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters

Secondary outcomes

  1. Major adverse limb events

    Time frame: 12months

    Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.

  2. Major adverse cardiovascular events

    Time frame: 12months

    Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.

Other outcomes

  1. All-cause deah

    Time frame: 12months

    All-cause deah during the follow-up period

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia

Acronym: POP-CLI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2022
Registry last updated
Sep 2, 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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