Peripheral Arterial Disease
Conditions
Interventions
Experimental group:Peripheral arterial paclitaxel-coated constrained balloon dilation catheter
Control group:Drug-coated balloon dilation catheter for the knee
Sponsors
Chinese PLA general Hospital Chinese PLA Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years old, regardless of gender 2. Atherosclerotic stenosis or occlusive lesions of the popliteal artery (including the tibiofibular trunk, anterior tibial artery, posterior tibial artery, and fibular artery) 3. Rutherford classification between grades 4-6 4. Estimated reference vessel diameter of target lesion is 2.0-4.0 mm, with target lesion vessel occlusion or stenosis =70% 5. Total length of target lesion =200 mm 6. Target lesion must be successfully pre-dilated (defined as residual stenosis <50%, no distal embolization, no flow-limiting dissection of grade C or above) 7. Ipsilateral inflow tract is patent or has been successfully recanalized (stenosis <50%) 8. Patient voluntarily participates and signs a written informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients whose target lesion site cannot be traversed by a guidewire 2. Patients with severely calcified target lesions (PACSS score grade 4) 3. Patients with in-stent restenosis at the target lesion 4. Patients with no target lesion outflow below the ankle joint 5. Patients requiring simultaneous intervention in both lower limbs 6. Patients whose other lesions undergoing simultaneous intervention use drug balloons or drug-eluting stents 7. Patients requiring thrombolysis or thrombectomy for acute thrombosis 8. Patients planning a major amputation above the ankle joint 9. Patients with coagulation disorders or a history of thrombocytopenic purpura 10. Patients with a history of thrombolysis or interventional treatment at the target lesion within 6 weeks before surgery 11. Patients who had a stroke within 3 months before surgery (excluding lacunar cerebral infarction) or acute myocardial infarction within 30 days 12. Patients with severe renal insufficiency, serum creatinine greater than twice the upper limit of normal 13. Patients with vascular access infection or systemic active infection 14. Patients with known allergies to paclitaxel or structurally similar compounds, contrast agents, aspirin, heparin sodium, clopidogrel, or other anticoagulant/antiplatelet drugs 15. Patients unable to receive the recommended antiplatelet and/or anticoagulant therapy 16. Patients currently participating in other pre-marketing drug or medical device clinical trials and have not yet completed the primary endpoints of those studies 17. Pregnant or breastfeeding women, or women planning pregnancy during the trial 18. Patients deemed by the investigator as unsuitable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesion at 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Technical success rate;success rate of operation;Primary patency rate of target lesion at 12 months after surgery;Target lesion restenosis rates at 6 and 12 months postoperatively;The improvement rate of ulcer wound healing at 6 and 12 months after surgery;The changes in Rutherford classification at 6 and 12 months postoperatively compared with the baseline.;The changes in ABI at 6 and 12 months post-operation compared with the baseline; | — |
Countries
China
Contacts
Public ContactGuo Wei
Chinese PLA general Hospital Chinese PLA Medical School
Outcome results
None listed