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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT03683459
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
2\. Patients with peripheral femoral or popliteal artery stenosis (greater than or equal to 70%) or occlusive disease;
3\. Rutherford classification graded 2-5；
4\. The subject or its legal representative can understand the purpose of the study, show sufficient compliance with the test protocol, and sign the informed consent.
Exclusion Criteria:
* 1\. Patient with arteritis;
2\. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
3\. Any cerebrovascular accidents within 3 months；
4\. Any unstable coronary heart disease or myocardial infarction within 3 months；
5\. Any important organ failure；
6\. Any known hypersensitivity to heparin, aspirin, clopidogrel, paclitaxel, paclitaxel compounds and contrast agents;
7\. Cannot accept antiplatelet and/or anticoagulation therapy；
8\. Patients with hemorrhagic physical diseases；
9\. Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；
10\. Serum creatinine \> 2mg/dl (177umol/L)；
11\. Pregnant or lactating woman；
12\. In the absence of intervention, the three lumens of tibialis anterior, tibialis posterior and peroneal artery stenosis or occlusion degree were all \>50%；
13\. iliac artery stenosis \>50%, or lumen stenosis \>50% after treatment (Limited to non-drug-eluting balloon or stent treatment only)；
14\. The guide wire cannot pass through target lesions (Passing through target lesions refers to the head of the guidewire arrive beyond the lesion in the absence of interlayer or perforation)；
15\. Severe calcification at target lesions and should not be treated with balloon dilatation therapy;
16\. Pre-dilation or anticipated severe vascular dissections after dilation;
17\. Residual stricture of \>50% or severe current-limiting dissection after pre-dilation is not suitable for simple balloon dilatation catheter treatment;
18\. The total length of target lesions is \>200mm, or the reference diameter of the target vessel was \>7mm or \<3mm;
19\. Life expectancy is less than one year;
20\. Participated in clinical trials of other drugs or instruments at the same time;
21\. Other conditions not suitable for inclusion judged by researchers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03683459
Study Brief:
Protocol Section:
NCT03683459