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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT04710420
Eligibility Criteria:
Inclusion Criteria:
1. patients \> 18 years of age;
2. patients with Chronic limb-threatening ischemia (CLTI);
3. patients with below-the-knee lesions undergoing endovascular treatment;
4. target limbs with certain WIfI stage;
5. patients voluntary and capable of follow-up;
6. informed consent.
Definition of CLTI:
A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).
Exclusion Criteria:
1. Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
2. Contrast agent allergy;
3. Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
4. Complications affecting surgical safety;
5. Major amputation was adopted to the target extremity;
6. The existence of aneurysm in the target vessels;
7. The existence of perforation, dissection or any other injury requiring intervention in the target vessels.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04710420
Study Brief:
Protocol Section:
NCT04710420