A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery

Summary

Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease. Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity. Calcification may also affect the outcome of endovascular therapy, leading to unsatisfactory vasodilation, and increase the risk of vascular complications (including restenosis) and dissection, perforation, and distal embolization. At present, according to the degree of calcification and the scope of the lesion, it can be divided into light, medium and severe three grades. Neither high pressure balloon nor atherectomy can significantly improve severe calcification. The efficacy of these treatments has also not been tested in multicenter, real-world studies. Shockwave balloon has been widely used in the clinical treatment of severe calcification due to its characteristics of significantly destroying the calcification structure, reducing the damage of vascular intima, and thus reducing postoperative complications. The currently published Disrupt PAD III Trial (NCT02923193) in calcified lesions showed shock wave balloon versus balloon expansion alone in a randomized controlled trial (RCT). The residual stenosis rate was lower (66.4% vs. 51.9%; p = 0.02), the incidence of fluid limiting intersections was low (1.4% vs. 6.8%; p = 0.03), the rate of post-expansion and recovery support was also low (5.2% vs. 17.0%; p = 0.001); (4.6% vs. 18.3%; p \< 0.001). The shock wave balloon has been approved by the China Food and Drug Administration for the intracavitary treatment of severe femoral popliteal artery calcification. Due to its short market-time, it is currently only used in large vascular surgery centers. On this basis, investigators propose whether can set up a real-world study of shock wave balloon in the treatment of moderate and severe calcification, in order to explore the real efficacy of shock wave balloon in the treatment of moderate and severe calcification.

Conditions

• Peripheral Arterial Disease

Sponsors & Collaborators

• RenJi Hospital

  collaborator OTHER

• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Dongfang Hospital Affiliated to Tongji University

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Qingdao Haici Hospital

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Quanzhou First Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Hainan Medical University

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-31

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• China

Study Locations