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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT05415995
Eligibility Criteria:
Inclusion Criteria:
* Age 18-85 years；
* ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
* Rutherford Category 3-6；
* Subjects are willing to sign informed consent；
Exclusion Criteria:
* Planned major limb amputation within 30 days after the procedure;
* In-stent stenosis in the target lesion;
* Severely calcified target lesions；
* Creatinine\>2.5mg/dL;
* History of allergies to anesthetics, contrast agents；
* Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
* Other circumstances judged by researchers that are not suitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05415995
Study Brief:
Protocol Section:
NCT05415995