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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT04277702
Eligibility Criteria:
Inclusion Criteria:
1. Patients with peripheral arterial disease qualified for endovascular treatment with Rutherford 3 or 4 clinical symptoms.
2. Age 45 - 75 years old.
3. Signed informed consent.
Exclusion Criteria:
1. Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms.
2. Age \< 45 or \> 75 years old.
3. Infection and/or fever (temperature above 37,2 C) within the last 3 weeks preceding the study recruitment (viral infections, cold, sinusitis) and use of antibiotics within the last 2 months.
4. Symptoms of acute tissue infection
5. Chronic inflammatory disease (e.g. COPD stage \>II in GOLD classification)
6. HIV+, HCV+, HBS+.
7. Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months.
8. Inflammatory blood vessel disorders (with exception of atherosclerosis)
9. Myocardial infarction or stoke within last 6 months.
10. Buerger Disease.
11. Chronic heart failure (3-4 NYHA)
12. Acute lower limb ischemia or surgical revascularization within last 6 months.
13. Serious trauma or surgery procedure within last 6 months.
14. Asthma.
15. On-going antileukotriene treatment.
16. Neoplasm diagnosed within 5 years.
17. Chronic Kidney Disease (creat. \>177 µmol/l).
18. Pregnancy, puerperium, women without efficient contraception.
19. Vaccinations within 30 days before recruitment.
20. Hospitalisation in intensive care unit within 3 months.
21. Lack of the possibility of the follow-up participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT04277702
Study Brief:
Protocol Section:
NCT04277702