Moderate to severe calcification lesions in the femoral-popliteal artery
Conditions
Interventions
Shockwave@ Intravascular Shockwave catheter system for treatment:None
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old; 2. Rutherford classification grade 2–5; 3. Femoral-popliteal artery stenosis (stenosis degree confirmed by DSA angiography >70%) or occlusion; there shall be one patent outflow tract distal to the knee that connects continuously with one patent outflow tract below the ankle; 4. Patients who understand the purpose of this study, voluntarily participate in the trial, sign informed consent forms and agree to follow-up visits; 5. Guidewire can pass through the lesion; 6. Life expectancy > 24 months; 7. Moderate to severe calcified lesions confirmed by imaging data; 8. Patients with interventions performed on both lower extremities can be enrolled sequentially according to the time of endovascular treatment; 9. Patients combined with aortoiliac artery lesions who have achieved blood flow recanalization via endovascular revascularization with residual stenosis less than 50%.
Exclusion criteria
Exclusion criteria: 1. Patients with stroke, cerebral hemorrhage, massive gastrointestinal hemorrhage or myocardial infarction within 3 months prior to enrollment; 2. Patients with known allergies to heparin, aspirin, other antiplatelet drugs, contrast agents and related agents; 3. Patients who received interfering medications or other special vascular preparation devices (e.g., plaque debulking devices, specialized balloons) within the past 3 months that may interfere with this clinical trial; 4. Pregnant and lactating women; 5. Patients who are unable or unwilling to participate in this trial; 6. Patients with Buerger’s disease; 7. Patients who have undergone arterial bypass surgery on the affected limb.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural Success Rate (PSR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Patency Rate (PPR) at 30 days postoperative;Rescue Stent Implantation Rate During Procedure;Improvement in Rutherford Classification at 1, 3, 6, and 12 months postoperative;Quality of Life Score at 1, 3, 6, and 12 months postoperative (assessed by Vas-QoL questionnaire);Freedom from Target Lesion Revascularization (F-TLR) at 1, 3, 6, and 12 months postoperative;Major Adverse Events (acute thrombosis related to procedure, arterial embolism, major amputation, and all-cause mortality) at 1, 3, 6, and 12 months postoperative;Device Success;Incidence of Major Adverse Events (MAEs) at 30 days postoperative; | — |
Countries
China
Contacts
Public ContactFeng Hai
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed