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 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT05084066
Eligibility Criteria:
Inclusion Criteria:
* Peripheral arterial disease, which causes claudication
* Patients who have given written informed consent and are undergoing conservative treatment for claudication (continuous treatment for at least three months)
* Patients with lower limb atherosclerosis Fontaine class IIA or IIB
* The primary limiter of walking is claudication, not any other condition
* Ankle-brachial index (ABI) ≤ 0,9 in symptomatic lower limb
Exclusion Criteria:
* Female gender
* Resting blood pressure \> 200 mmHg
* Fontaine class III or IV
* eGFR \< 30 ml/min/1,73 m2
* Home oxygen therapy or severe COPD (GOLD 3-4)
* Heart failure NYHA III-IV
* Stable angina pectoris
* Clinically severe COVID-19 infection in the last three months
* History of malignancy (within the last five years)
* Persistent or permanent atrial fibrillation or flutter
* Acute myocardial infarction in the last three months
* Residual signs of cerebral infarction that impede movement
* Significant atherosclerosis of peripheral arteries of the upper limb (symptomatic)
* History of deep vein thrombosis of the upper limb
* Diabetic polyneuropathy
* Under 18 years of age
* Patients who are unable to follow the study regimen
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05084066
Study Brief:
Protocol Section:
NCT05084066