There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level. Therefore, in this study, we wish to set up a real-world study of shockwave balloon in the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloon in the treatment of moderate-to-severe calcified lesions.
None
Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment (2) Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
Patients diagnosed with PAD.
Cohort
Prospective
Shockwave balloons
DeviceTo evaluate the effectiveness and safety of the Shockwave intraperipheral shockwave catheter system in peripheral arterial angioplasty.
Procedural Success Rate
Residual stenosis \<50% with no flow-limiting entrapment after study device therapy (before subsequent endovascular device therapy).
Primary Patency Rate
Primary patency of target lesions at 30 days postoperatively
Freedom from clinically-driven target lesion revascularization(CD-TLR)
Clinically driven target lesion revascularization is defined as target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed.
Clinical improvement
Improvements in Rutherford grading
Vascular quality of life questionnaire(VascuQol)
The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.
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Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Huashan Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
The General Hospital of Southern Theater Command
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
RenJi Hospital
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
