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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT04148456
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 years and older patients.
2. Patient presented with disabling claudication pain.
3. Patient presented with rest pain.
4. Patient presented with gangrene or atrophic changes.
5. Provided written informed consent.
6. Eligible anatomy for CERAB technique.
7. TASC- (II) classification as assigned in the study protocol (specified type B, C and D lesions).
Exclusion Criteria:
1. Age less than 18 years old.
2. Patients with acute limb ischemia.
3. Patients treated with open surgery and other endovascular techniques such as kissing stenting.
4. CERAB configuration extending into aneurysmatic infrarenal aorta.
5. Patient's life expectancy \<2 years as judged by the investigator.
6. Patient has a psychiatric or other condition that may interfere with the study.
7. Patient has a known allergy to any device component.
8. Patients with a systemic infection who may be at increased risk of endovascular graft infection.
9. Patient has a coagulopathy or uncontrolled bleeding disorder.
10. Patient had a recent cerebrovascular accident (CVA) or a myocardial infarction (MI) within the prior three months.
11. Patient is pregnant (Female patients of childbearing potential only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04148456
Study Brief:
Protocol Section:
NCT04148456