POP-CLI: Peri-operative Foot CT Perfusion in CLI Patients

Fudan University (Other)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: computed tomographic perfusion

Study Design

Study Type:
Anticipated Enrollment :
90 participants
Observational Model:
Time Perspective:
Official Title:
The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Outcome Measures

Primary Outcome Measures

  1. Pre-operative computed tomographic perfusion parameters [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 [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 [18months]

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

Secondary Outcome Measures

  1. Major adverse limb events [12months]

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

  2. Major adverse cardiovascular events [12months]

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

Other Outcome Measures

  1. All-cause deah [12months]

    All-cause deah during the follow-up period

Eligibility Criteria


Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Hua Dong Hospital Affiliated to Fu Dan University Shanghai China

Sponsors and Collaborators

  • Fudan University


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Zhijun Bao, Director, Fudan University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 2022KW
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2022