Moderate to severe calcification lesions of the femoral-popliteal artery
Conditions
Interventions
Test group:Peripheral intravascular shock wave catheter and intravascular shock wave energy system
Control group:Peripheral balloon dilation catheter
Sponsors
Shanghai Ninth People’s 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. Rutherford classification of 2 - 5; 3. Resting ABI of the target - side limb 1 year; 6. According to the diagnosis of medical institutions or participating researchers, the need to receive peripheral artery angioplasty (including using a peripheral intravascular shock - wave catheter and intravascular shock - wave energy system or a peripheral balloon dilation catheter for lumen preparation, followed by drug - coated balloon treatment or stent implantation); Imaging inclusion criteria: 7. The target lesion is located in the superficial femoral artery (SFA) or popliteal artery (the popliteal artery extends to the proximal opening of the anterior tibial artery and ends); 8.The target vessel has not undergone various surgical interventions including endovascular treatment and open surgery within the past 3 months, and the stenosis rate is >= 50% or it is an occlusive lesion as evaluated pre - operatively; 9. The diameter of the target vessel is 2 - 7.5mm, and there is at least one normal infrapatellar runoff artery (stenosis rate = 50mm and = 100mm, the length of the calcified lesion should be greater than 50mm. 12. If there are signs of acute or chronic thrombosis in the target vessel, patients who meet the above conditions after routine clinical treatment. Note: Patients whose inflow and outflow tracts meet the inclusion criteria of this trial after routine clinical treatment can be included.
Exclusion criteria
Exclusion criteria: 1. Rutherford classification is grade 0, 1, or 6; 2. There is a severe infection in the target limb that requires the use of antibiotics, or amputation above the ankle is planned; 3. The target limb has undergone endovascular treatment or open surgical treatment within the past 1 month; 4. Patients with known allergies or contraindications to the raw materials or drugs of the test product (such as antiplatelet drugs, anticoagulant drugs); 5. Patients who cannot receive antiplatelet or anticoagulant therapy; 6. History of stroke or myocardial infarction within 60 days; 7. Subjects who are simultaneously participating in other medical device or drug clinical trials; 8. Pregnant or lactating women; 9. Other situations that the investigator deems unsuitable for participating in the clinical trial; Imaging exclusion criteria: 10. In - stent restenosis; 11. Highly tortuous arteries; 12. There are other significantly untreated vascular lesions (stenosis rate > 50%) in the inflow vessels upstream of the target lesion area; 13. There are aneurysms in the target vessels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical Success Rate,TSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Patency Rate, PPR;AnkleBrachialIndex,ABI;Rutherford classification 30 days after surgery;Evaluation of Equipment Performance;Intraoperative complications;The incidence of major adverse events 30 days after the operation;Device defects (only applicable to the experimental group);On-site instrument performance evaluation (only for the experimental group);AE and SAE;Vital signs (blood pressure, pulse, respiration, body temperature) and physical examination;Clinical laboratory tests; | — |
Countries
China
Contacts
Public ContactLu Xinwu
Shanghai Ninth People’s Hospital
Outcome results
None listed