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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT04716361
Eligibility Criteria:
Inclusion Criteria:
1. Rutherford stages 2-6
2. The target vessel (femoral and/or popliteal artery) has at least ≥90% stenosis or occlusion with the moderate to severe calcification (defined as \>5 cm continuous calcification)
3. For patients with both lower limbs to be treated, the side with severer calcification is selected. If the calcification is similar in the two sides, the first one to be treated is selected.
4. At least one outflow artery (which is patent in \> 1/3 length) in the calf connects the popliteal artery.
5. Patients who failed the first treatment because the guide wire could not pass through the lesion can still be selected if the second endovascular treatment succeeds.
6. There is no restriction on the types of endovascular techniques and devices.
Exclusion Criteria:
Exclusion Criteria:
1. Life expectation less than one year
2. There is several infection and/or major tissue loss in the leg. Even if after revascularization, patient still need amputation.
3. The quality of patients' life cannot be assessed by vascular quality of life questionnaire due to difficulties in communication.
4. Chronic femoropopliteal occlusive disease without calcification.
5. Patients with acute arterial thrombosis.
6. Limbs that have been treated with the femoral and popliteal artery bypass surgery.
7. Pregnant women
8. Allergic to contrast medium
9. Participating in other drug or device studies currently.
10. Systematic infection and/or coagulation disorders 14 days before the enrollment.
11. Patients have severe systematic disease that cannot be controlled currently such as severe heart, lung disease, live function disorder, end stage cancer, etc
12. Stroke, myocardial infarction, bleeding in the past 6 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04716361
Study Brief:
Protocol Section:
NCT04716361