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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT04698304
Eligibility Criteria:
Inclusion Criteria:
1. Patients over 18 years old
2. Patients with Rutherford classification range from 3 to 6
3. If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study
4. The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle
5. The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion
6. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
7. For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery
8. Informed consent signed by patients
Exclusion Criteria:
1. Patients who are unwilling or refuse to sign the informed consent form
2. Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism
3. Patients with thromboangiitis obliterans
4. Patients with failure of endovascular treatment, and transferred to bypass surgery
5. Patients who underwent surgical atherectomy for common femoral artery occlusive lesions
6. Patients with known allergy to heparin, low molecular weight heparin and contrast agents
7. Patients who have been enrolled in other clinical trials in the past 3 months
8. Women during pregnancy and lactation
9. Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (\< 3 years), such as tumors, severe liver disease, cardiac insufficiency
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04698304
Study Brief:
Protocol Section:
NCT04698304