Calcified lesions of peripheral arterial stenosis
Conditions
Interventions
test group:Vascuwave single-use peripheral intravascular shock wave catheter and ECCD-041 Intravascular Shockwave Therapy Device of VascuPatent Medical (Shenzhen) Co, Ltd.
control group:Shockwave Peripheral Intravascular Lithotripsy(IVL) Catheter and Intravascular Lithotripsy Generator and Connector Cable of Shockwave Medical Inc
Sponsors
Shanghai Jiaotong University School of Medicine,Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. age 18-85 years inclusive; 2. Rutherford Clinical Classification 2-5; 3. the target lesion is located in the superficial femoral and/or popliteal arteries; 4. the target lesion has a reference vessel diameter (visual inspection) of 2.5-7.0 mm; 5. the target lesion has a stenosis (visualized) of =70%. 6. the total length of the target lesion is =250mm (if there is an occlusive lesion, the length of the occluded segment is =150mm); 7. moderately severe calcified lesions on imaging; 8. the presence of at least one patent outflow tract; 9. understand the purpose of the trial, voluntarily agree to participate in the study and sign the informed consent form, and be willing to follow up the clinical follow-up according to the requirements.
Exclusion criteria
Exclusion criteria: 1. there is an active infection in the target limb 2. the target limb is scheduled for amputation above the ankle; 3. the target lesion is in-stent restenosis; 4. the presence of an aneurysm in the target vessel 5. the target vessel has a thrombosed lesion requiring thrombolysis or thrombectomy 6. failure of the guidewire to pass through the lesion; 7. severe stenosis or occlusion of the P3 segment of the popliteal artery; 8. the same hospitalization requires intervention of both lower extremities; 9. a history of major surgical intervention within 30 days or planned major surgical intervention within 30 days 10. myocardial infarction within 30 days; 11. a plasma creatinine clearance of less than 30 ml/min; 12. subjects with coagulation disorders, bleeding disorders, or thrombocytopenia with platelet counts less than 0.1/L; 13. known hypersensitivity or contraindication to antiplatelet or anticoagulation therapy, or known hypersensitivity to contrast media, medications or catheter materials used in endovascular therapy; 14. life expectancy < 1 year; 15. women who are pregnant or breastfeeding; 16. subjects who have participated in clinical trials of other medical devices or drugs during the same period of time; 17. other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in a clinical trial. Note: PARC Criteria for Calcification: Localized: <180° (vascular side) and less than half the total length of the lesion; Mild: <180° (one side of the vessel) and the length of calcification is greater than half of the total length of the lesion; Moderate: =180° (both sides of the vessel), and the length of calcification is less than half of the total length of the lesion; Severe: =180° (both sides of the vessel), and the length of calcification is greater than half of the total length of the lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Procedural Success Rate, PSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Patency Rate, PPR;Changes in ABI at 30 days postoperatively;Improvement in Rutherford classification at 30 days postoperatively;Instrument success rate;Evaluation of Intravascular Shockwave Therapy Devices; | — |
Countries
China
Contacts
Public ContactLan Zhang
Shanghai Jiaotong University School of Medicine,Renji Hospital
Outcome results
None listed