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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04323033
Eligibility Criteria:
Inclusion Criteria:
1. De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long.
2. Ability to cross the lesion with guidewire (assessed during diagnostic angiography).
3. ABI ankle-brachial index \<0.9.
4. Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4.
5. Age ≥ 18 years.
6. Patient signed informed consent form.
Exclusion Criteria:
1. Life expectancy less than two years.
2. Chronic kidney disease in stage III-V.
3. Lesion in the previously implanted by-pass.
4. Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization.
5. Acute lower limb ischemia.
6. Stenosis (\> 50%) or occlusion proximally to the lesion being treated.
7. Angiographically confirmed thrombus in the lesion to be treated.
8. Treatment requires an atherectomy to deliver stent to treated lesion.
9. Known allergy or hypersensitivity to clopidogrel.
10. Hemorrhagic stroke in the last three months.
11. Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis).
12. Pregnancy or women of childbearing potential not using effective contraception.
13. Active inflammation at the planned access site.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04323033
Study Brief:
Protocol Section:
NCT04323033