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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT03423732
Eligibility Criteria:
Inclusion Criteria:
* Patients able to walk
* Male and female patients, aged 18-80 years
* No-option CLI (definition: exhausted revascularization options including surgery or endovascular treatment) in Rutherford stage 4-5
* In case of bilateral N-O CLI, the limb with shorter claudication distance will be treated
* Presence of adequate inflow (patent iliac and common femoral arteries)
* Run-off through at least one (even partially seen) below-the-knee (BTK) artery
* Signed informed consent
Exclusion Criteria:
* Malignancy
* Moderate or severe immunodeficiency
* Acute or chronic bacterial or viral infectious disease
* Soft tissue disease or local infection in a place of required artery puncture
* Pregnancy or breastfeeding
* Any objective or subjective reason for inability to attend follow-up visits
* Females of childbearing potential, who does not want to use a highly effective method of contraception
* Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
* Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
* Life expectancy \< 1 year
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03423732
Study Brief:
Protocol Section:
NCT03423732