Lower extremity arteriosclerotic obliterans with moderate or higher calcification
Conditions
Interventions
Experimental group: C-Wave intravascular shock waveguide system for lumen preparation:None
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age > 18 years old (excluding the lower limit); 2) The patient has primary or restenosis of lower extremity arteriosclerosis obliterans requiring intervention; 3) The affected limb meets the Rutherford scale 2~6; 4) Moderate or severe calcification of the affected limb (PACSS 2-4) : 5) Agree to participate in this study and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1) Subjects assessed by the investigator as not suitable for the use of shock wave balloon catheter dilation or have contraindications for the use of shock wave balloon catheter dilation; 2) The subjects have been enrolled in other clinical studies and there are circumstances that interfere with the study results. 3) Other conditions that the investigator deems inappropriate for clinical trial participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of immediate residual lumen stenosis was less than 30%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success;Primary patency rate of target lesions;Clinical driven revascularization rate of target lesion;Residual lumen stenosis after treatment with a shock balloon and immediately after surgery;ABI change;Rutherford grading changes;Intraoperative complication;Instrument defect;Field instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactXiangchen Dai; Lianrui Guo
Tianjin Medical University General Hospital/Xuanwu Hospital, Capital Medical University
Outcome results
None listed