Peripheral Arterial Disease
Conditions
Interventions
Experimental group:Drug-eluting PTA balloon catheter
Control group:Drug-eluting peripheral balloon dilation catheter
Sponsors
Chinese PLA general Hospital Chinese PLA Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18=D) flow-limiting dissection, no thrombosis, embolism or other serious adverse events); 8. Patients who have at least one autologous infrapopliteal artery that can be patented in the foot on the affected side (i.e., diameter stenosis <50%) after preoperative or intraoperative treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with non-lower extremity arteriosclerotic lesions (such as vasculitis or Berger's disease, etc.); 2. Patients with severe abnormal coagulation function or uncontrolled severe infection that is not suitable for surgery; 3. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.; 4. Patients who have had a distal amputation of the affected limb or the contralateral limb (above the metatarsal) in the past; 5. Patients who have received local or systemic thrombolytic therapy within 48 hours before surgery; 6. Patients who have had acute myocardial infarction within 30 days before surgery; 7. Patients who have had a hemorrhagic stroke within 3 months; 8. Patients who have undergone major surgical procedures (cardiac, abdominal, or peripheral vascular open surgery) within 30 days prior to surgery; 9. Patients with a life expectancy of less than 12 months; 10. Patients whose target lesions are restenotic after drug balloon or drug stent or bypass surgery; 11. Patients with target lesions requiring adjuvant therapy (such as atherectomy, laser therapy, cryogenic angioplasty); 12. Pregnant or lactating women; Those who are planning to become pregnant or are trying to become pregnant in the near future; Men whose spouses are pregnant and whose spouses are lactating; 13. Patients who have participated in clinical trials of other drugs or medical devices within three months; 14. Patients who are not suitable to participate in this study in the opinion of the investigator; 15. Severe (>=D) flow-limiting dissection with pre-expansion of the target lesion; 16. Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e., residual stenosis is still >=30% after treatment); 17. There is no autologous infrapopliteal artery that is available for patency of the foot on the affected side (i.e., diameter stenosis >=50%) after preoperative or intraoperative treatment; 18. When the target lesion is a tandem lesion, the spacing between the two adjacent lesions is > 20mm; 20. Acute or subacute thrombosis in the target vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary patency rate 12 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Surgical success rate;Clinical success rate;Remedy the stent implantation rate;The incidences of TLR and CD-TLR at 30 days, 6 months and 12 months after the operation;The incidences of TVR and CD-TVR at 30 days, 6 months and 12 months after the operation;The incidence of all-cause mortality at 30 days, 6 months and 12 months after the operation;The time of the first CD-TLR within 12 months after the initial surgery;Rutherford classification changes;The change of ankle-brachial index (ABI);The incidence of major amputation (above the ankle joint) and minor amputation (below the ankle joint) of the treated lower extremity; | — |
Countries
China
Contacts
Public ContactGuo Wei
Chinese PLA general Hospital Chinese PLA Medical School
Outcome results
None listed