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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT04675632
Eligibility Criteria:
Inclusion Criteria:
* 1\) Rutherford stages 2-5. 2) The femoral and popliteal artery as the target of the study has at least ≥70% stenosis or occlusion.
3\) Whether it is a primary femoral and popliteal artery disease or in-stent restenosis, patients who received endovascular recanalization successfully (Residual stenosis \<30% and no flow-limiting arterial dissection) can be enrolled in the group.
4\) For the patients with both lower limbs to be treated, both limbs can be selected into the group.
5\) Patients who failed the first treatment because the guide wire could not pass through the lesion can still be included in the group after successful endovascular interventional treatment.
6\) Patients who understand the purpose of this research, volunteer to participate in the experiment, sign an informed consent form and are willing to be followed up can be included in the experiment.
7\) For ipsilateral aortoiliac artery disease, patients with residual stenosis \<30% can also be included in the group after intravascular reconstruction.
Exclusion Criteria:
* 1\) Patients with acute arterial thrombosis. 2) Patients with serum creatinine level\> 176μmol/L. 3) Patients with Rutherford stage 5 have foot infection grades of 2 and 3 in the preoperative WIFI (WIfI) classification.
4\) Limbs that have been treated with the femoral and popliteal artery bypass surgery.
5\) Patients who are known to be allergic or sensitive to contrast agents, heparin, aspirin (ASA), other anticoagulant or antiplatelet therapies, and/or paclitaxel.
6\) Patients with bleeding constitution. 7) Pregnant and lactating women. 8) Patients with a history of myocardial infarction or unstable angina within 3 months.
9\) Patients with a history of TIA or cerebral infarction within 3 months. 10) Patients with severe disease such as liver failure. 11) Patients with a life expectancy of less than 24 months. 12) Participating in other drug or device studies currently. 13) Patients with poor treatment compliance or deemed unsuitable for inclusion in the group by the researcher.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04675632
Study Brief:
Protocol Section:
NCT04675632