Critical Limb Ischemia: Perfusion Computed Tomography.

Completed

• Conditions: peripheral vascular disease and atherosclerosis of the lower limb; 10047043; 10003216

• Registration Number: NL-OMON40070
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- rest pain, nonhealing ulceration or gangrene of the foot, i.e. Fontaine III/IV
- ankle-brachial pressure index (ABPI) < 0.7 or toe pressure < 50 mmHg
- critical limb ischemia > 2 weeks
- normal renal function (i.e. creatinine <130*mol/l)
- written informed consent

Exclusion Criteria

- inability to give informed consent
- contraindications for contrast-enhanced CT, i.e. allergic reactions to iodinated contrast agents or pregnancy
- major amputation; amputation above the level of the ankle
- patient participates in another study

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Signal/contrast to noise ratio of the PCT scans<br /><br>- PCT imaging quality scores<br /><br>- PCT perfusion values (blood volume, blood flow, time to peak and mean transit<br /><br>time) of different predefined regions of the ischemic and non-ischemic foot<br /><br>- Pedal arterial patency based on DSA</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>No secundary study parameters/outcomes</p><br>