Calcification of peripheral arteries
Conditions
Interventions
Experimental group:Peripheral arterial shock wave lithotripsy system
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old and =80 years; 2. Patients who were clinically diagnosed as arteriosclerosis obliterans of lower limbs and planned to undergo percutaneous transluminal angioplasty (PTA); 3. Rutherford clinical classification is Grade 2-5; 4. Target lesions are vascular calcification lesions (PARC grade II-IV); 5. Patients or their guardians can understand the purpose of the study, voluntarily participate in and sign written informed consent, and can accept follow-up visits. 6. The target lesion is located in the femoral artery and/or the popliteal artery and is primary; 7. The total length of the target lesion (stenosis =70%) is no more than 200 mm, and the length of the occlusioned segment is no more than 100mm; 8. The reference diameter of the target vessels is between 2.5mm and 7.0mm; 9. Patients with unobstructed inflow tract (including ipsilateral iliac artery, common femoral artery, and upper superficial femoral artery) or successfully treated (i.e., visual residual stenosis =30% after treatment, no serious (grade =D) current-limiting dissection); 10. Angiography showed at least one outflow tract was unobstructed at the distal end (visual narrowing of lumen diameter < 50%).
Exclusion criteria
Exclusion criteria: 1. Patients with active limb infection on the affected side; 2. Patients with known allergies to aspirin, clopidogrel, heparin, contrast agents, catheter materials, etc.; 3. Patients who are planning to have major lower limb amputations (above the ankle) on the target side of the lesion; 4. Patients with target vessels of artificial blood vessel transplantation; 5. Patients with acute or chronic kidney disease (e.g., serum creatinine >2.5 mg/dL or >220 umol/L) or dialysis; 6. Patients with known coagulation disease or bleeding tendency (platelet count less than 60×109/L); 7. Patients with contraindications for antiplatelet, anticoagulant or thrombolytic therapy; 8. Patients who had received target vessel catheterization thrombolytic therapy within 2 weeks before surgery; 9. Patients who had received vascular interventional surgery or major surgery within 3 months before surgery; 10. Patients with myocardial infarction or stroke within 3 months before surgery; 11. Life expectancy is less than 6 months or it is expected to be difficult to complete the follow-up; 12. Women who are pregnant or breast-feeding, or women of childbearing age who have family plans during the study period or who cannot use adequate contraception; 13. Participating in clinical trials of other drugs or devices; 14. Other reasons are not considered suitable for the candidate. 15. The target lesion was any patients with in-stent restenosis; 16. Aneurysms or acute or chronic thrombus in target vessels; 17. Patients with highly curved target lesions (visual radian greater than 30°).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;No major adverse events (MAE) occurred within 1 month after surgery;The incidence of clinically driven target lesion revascularization at 1 and 6 months after surgery;Vascular patency rate at 1 month after operation;The incidence of thrombus or distal embolism in the lower extremity arteries of the target side immediately after surgery;The incidence of major amputation (above the ankle) and minor amputation (below the ankle) at the treatment side at 1 and 6 months after surgery;Ankle-brachial index (ABI) changes at 7 days after surgery or at discharge and 1 month follow-up;Rutherford clinical grading changes;Incidence of surgery-related complications;Other adverse events and incidence of serious adverse events during the study period; | — |
Countries
China
Contacts
Public ContactXiangChen Dai
Tianjin Medical University General Hospital
Outcome results
None listed