Lower extremity arteriosclerosis obliterans
Conditions
Interventions
Test group:The APT shockwave therapy system will be used to treat peripheral arterial calcified lesions
Sponsors
Tian Jin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old; 2. Rutherford is graded on a scale of 2-5; 3. Clinically diagnosed with lower extremity arteriosclerosis occlusion, and percutaneous transluminal angioplasty (PTA) is to be performed; 4. The target lesion is located in the femoral artery (which can extend to the external iliac artery) or popliteal artery (which can extend to the opening of the anterior tibial artery); 5. The target lesion meets the following imaging criteria: (1) The target lesion is moderate or severe vascular calcification; (2) The total length of the target lesion <=200mm; If the target lesion is a chronic occlusive lesion, the length of the occlusive segment <=100mm; (3) The reference diameter of the target lesion blood vessel is 2.0mm-7.5mm; (4) At least one inferior knee artery was unobstructed in the outflow tract of the target lesion (the narrowing rate of the lumen diameter of the blood vessel was <50%); 6. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Major amputation above the ankle of the lower limb on the affected side within 30 days is planned; 2. The guidewire is unable to pass through the inflow tract and target lesions; 3. Target vessel combined with aneurysm or acute thrombosis; 4. The target lesion is located in an artificial vascular graft or stent; 5. The target vessel has received catheter thrombolysis therapy within 2 weeks before surgery; 6. Preoperative creatinine> 2.5 mg/dL or >221 umol/L or dialysis; 7. APTT>2.5 times the upper limit of normal/platelet<50×10^9/L; 8. Have undergone major surgical surgery within 3 months before surgery; 9. Received target vascular intervention or target vascular surgery within 3 months before surgery; 10. Myocardial infarction or stroke within 3 months before surgery; 11. Life expectancy is less than 1 year; 12. Known contraindication or severe allergy to contrast, anticoagulant, or antiplatelet agents; 13. Dementia, mental abnormality, or a history of mental illness that cannot cooperate voluntarily; 14. Females of childbearing age who are lactating, pregnant, and planning to become pregnant; 15. Participation in other interventional clinical trials; 16. Not suitable for inclusion in this trial as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion patency rate within 30d;Improvement rate of ABI;Incidence of MAE within 30d;Incidence of amputation below/above the ankle of the affected lower limb within 30d;Incidence of CD-TLR within 30d ;Incidence of AE;Incidence of SAE;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactDai Xiangchen
Tian Jin Medical University General Hospital
Outcome results
None listed