Peri-operative Foot CT Perfusion in CLI Patients (POP-CLI)

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

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

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Diagnostic test: computed tomographic perfusion

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Hua Dong Hospital Affiliated to Fu Dan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with critical limb ischemia, who completed both pre- and post-operative CTP workups

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative computed tomographic perfusion parameters	Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization.	18months
Post-operative computed tomographic perfusion parameters	Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization.	18months
Alteration of computed tomographic perfusion parameters	Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters	18months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse limb events	Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.	12months
Major adverse cardiovascular events	Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.	12months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause deah	All-cause deah during the follow-up period	12months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Wan Zhang, PH.D., Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: 2022KW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No