Atherosclerosis of lower limbs
Conditions
Interventions
Test group:Use the peripheral shock wave balloon catheter produced by Shenzhen Shunmei Medical Co., Ltd. for treatment
Control group:Treatment using peripheral balloon expandable catheter produced by Dingke Medical Technology (Suzhou) Co., Ltd
Sponsors
Teda International Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Age>=18 years old; 2. Those with a Rutherford grade of 2~5; 3. ABI 1 year; 5. Patients with clinical diagnosis of lower extremity arteriosclerosis occlusion, suitable for pre-dilation including intravascular shock wave system or peripheral intravascular balloon dilation catheter, and subsequent drug-loaded balloon catheter and stent catheter; 6. Able to understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and willing to undergo angiography and clinical follow-up. Imaging Inclusion Criteria: 7. The target lesion is located in the superficial femoral artery (SFA) or popliteal artery (the popliteal artery extends proximal to the opening of the anterior tibial artery and ends); 8. The target vessel has not undergone various surgical interventions including endovascular therapy and open surgery, and the stenosis rate is >=70% after preoperative evaluation; 9. The reference diameter of the target vessel is 2~7.5mm, and there is at least one normal sub-knee outflow artery (stenosis rate=100mm, the calcification length should be at least >=50mm. 13. Patients with ipsilateral iliac artery patency or ipsilateral iliac artery lesion and successful prior management (i.e., residual stenosis after treatment=D) flow-limiting dissection, no thrombosis, embolism, or other serious adverse events) Note: Patients who meet the enrollment conditions of this trial after routine clinical treatment in advance and outflow tract can be included.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Those who have a serious infection requiring antibiotics on the target limb or who plan to undergo above-knee amputation; 2. Those who have undergone intravascular treatment or open surgery in the past 1 month; 3. Those who are unable to accept antiplatelet drugs, anticoagulant drugs, contrast agents, and allergies to carbamate, nylon, and silicone components due to various reasons; 4. Those who are known to have abnormal coagulation function; 5. Those with a history of stroke or myocardial infarction within 60 days; 6. Patients with acute or chronic kidney disease (such as serum creatinine > 2.5 mg/dL or >220 umol/L); 7. Patients with acute thrombosis who require thrombolysis and thrombectomy; 8. Those who have participated in clinical trials of other medical devices or drugs during the same period and have not been out of the group; 9. Women who are pregnant or breastfeeding; 10. Those who have other conditions that the investigator considers unsuitable to participate in clinical trials. Imaging Exclusion Criteria: 11. The target lesion is in-stent restenosis; 12. The target lesion is a highly tortuous artery; 13. There are other obvious vascular lesions (stenosis rate > 50%) in the inflow blood vessels upstream of the target lesion area; 14. Patients with target intravascular aneurysms or a large number of acute or subacute thrombosis that have not been treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesions 30 days after surgery;Ankle Brachial Index (ABI) at 30 days postoperatively;Rutherford classification 30 days after surgery;Device performance evaluation (only applicable to experimental group devices); | — |
Countries
China
Contacts
Public ContactLi Xuedong
Teda International Cardiovascular Hospital
Outcome results
None listed