Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT02128750
Eligibility Criteria:
Inclusion Criteria:
* Men and women over 40 years
* Patients with chronic critical limb ischemia as defined by consensus TASC 2 and eligible to a revascularisation
* Objective evaluation of critical ischemia is based on ankle pressure \< 70 mm Hg or toe pressure \< 50 mm Hg for patients with ulcer or pressure ankle pressure \< 50 mm Hg or toe pressure \< 30 mm Hg for patients with rest pain.
* Patient's consent signed
Exclusion Criteria:
* Patients under 18
* Pregnant or breast feeding woman
* Burger's disease
* Contra- indication to use of contrast
* Hypersensitivity to sulfurhexafluorure
* Unstable coronary heart disease, acute stroke, uncompensated heart failure
* Right to left shunt
* Serious pulmonary hypertension (\> 90 mm Hg)
* Uncontroled increased blood pressure
* Acute respiratory distress syndrom
* Consent refused
* Patients with leg wounds preventing ultrasonography
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02128750
Study Brief:
Protocol Section:
NCT02128750