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

NCT ID: NCT06636968

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2028-06-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients older than 18 years
• Rutherford scale: Grades 2-5.
• Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
• The stenosis degree of the lesions was more than 70% confirmed by DSA, including chronic occlusive lesions.
• At least one sub-knee branch artery is patent (defined as a run-off score of 1 or less). • In-stent restenosis or restenosis with moderate to severe calcification.
• The stenosis degree of inflow blood vessel on the diseased side is less than 30% or the residual stenosis is less than 30% after first-stage treatment.
• Calcification lesions with thrombus can also be included in the group after the thrombus is completely cleared.
• Sign relevant informed consent.

Exclusion Criteria

• Active infection of the affected limb.
• Patients with severe ischemia of the affected limb who are expected to undergo major amputation.
• The target blood vessels were artificial blood vessels or autologous vessels.
• Simple thrombosis lesion.
• Thromboangiitis obliterans, arteritis or connective tissue disease-based lesions.
• Inflow vessel stenosis is greater than 30% or residual stenosis is still greater than 30% after primary treatment.
• Allergic to contrast agent, heparin, anti-platelet therapy.
• Patients who are pregnant or lactating.
• Patients with cardiovascular and cerebrovascular events such as stroke or myocardial infarction within 3 months prior to enrollment.
• Patients who are currently in an ongoing interventional clinical study program.
• Patients who refuse to sign informed consent. •
• Patients who refuse to cooperate with long-term follow-up after surgery or who, for personal reasons, have difficulty communicating for quality of life assessment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Dongfang Hospital Affiliated to Tongji University

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Qingdao Haici Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Quanzhou First Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Hainan Medical University

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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Other Identifiers

B2024-270

Identifier Type: OTHER

Identifier Source: secondary_id

The STRIKE study

Identifier Type: -

Identifier Source: org_study_id