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Not yet recruiting NCT07113197

Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia

No phase Interventional Chronic Threatening Lower Limb Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional angiography.
Who it may be relevant to
Registry conditions: Chronic Threatening Lower Limb Ischemia. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Diagnostic Value of Duplex Ultrasound in Evaluating Infra Inguinal Arteries in Patients With Chronic Limb Threatening Ischemia : A Comparative Study With Angiography

Overview

This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the reference standard. By comparing sensitivity, specificity, and predictive values across arterial segments, the study seeks to determine the clinical utility of DUS as a non-invasive alternative for pre-intervention vascular mapping in chronic limb-threatening ischemia.

Interventions

  • Radiation conventional angiography
    * Peak systolic velocity (PSV) * Velocity ratios * Segment visualization quality * Degree of stenosis

Primary outcome measures

  • Diagnostic accuracy of DUS compared to DSA in detecting ≥50% stenosis or occlusion in femoral, popliteal, and infra popliteal arteries. [Time frame: from enrollment till angioplasty (14 days mostly)]

Eligibility criteria

Inclusion criteria

\- 1. Clinical diagnosis of chronic threatening lower limb ischemia (rest pain, non-healing ulcer, or gangrene).

2\. Ability to provide informed consent.

Exclusion criteria

  • 1\. Hemodynamically unstable patients not fit for angiography. 2. Patients with non-atherosclerotic arterial diseases (e.g., vasculitis, Buerger's disease).

3\. Known contrast allergy or renal insufficiency precluding contrast angiography.

4\. Inadequate acoustic window or inability to undergo complete DUS examination.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Egypt · 1 center
  • Sohag University Hospital — Sohag

Identifiers

NCT: NCT07113197 · Soh-Med-25-7-22MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗