Using shockwave balloons to treat severe calcification in leg arteries

Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy (IVL) Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries

This study is testing whether shockwave balloon therapy can help people with peripheral artery disease who have severe calcification in their leg arteries feel better and improve blood flow.

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06713850 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the real-world efficacy of shockwave balloon therapy for treating moderate-to-severe calcification in the femoropopliteal artery among patients with peripheral artery disease (PAD). The study will involve patients who have significant stenosis or occlusion in the affected artery and will assess outcomes based on the ability of the shockwave balloons to disrupt calcified structures while minimizing vascular damage. The research is motivated by the need for effective treatment options for severely calcified lesions, which are often resistant to traditional therapies. Participants will be monitored for complications and treatment effectiveness over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with Rutherford Classification 2-5 and confirmed severe calcification in the femoropopliteal artery.

Not a fit: Patients with a history of stroke, cerebral hemorrhage, or other severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with severe calcification in leg arteries, reducing complications and enhancing blood flow.

How similar studies have performed: Previous studies, such as the Disrupt PAD III Trial, have shown promising results for shockwave balloon treatment in similar patient populations.

Eligibility criteria

Inclusion Criteria:

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1\) Age ≥ 18 years (2) Rutherford Classification 2-5 3) Stenosis (\>70% stenosis confirmed by digital subtraction angiography (DSA) imaging) or occlusion of the femoropopliteal artery, with one healthy patent outflow tract distal to the knee in continuity with a patent outflow tract below the ankle.

(4) Patients who understand the purpose of the study, participate in the experiment voluntarily, sign the informed consent form and are willing to be followed up.

5\) The guidewire needs to pass through the lesion; 6) Life expectancy \>24 months 7) Moderately severe calcified lesions confirmed by imaging data: 8) For patients who receive intervention in both lower extremities may be enrolled in order of time of intracavitary treatment 9) For combined aortoiliac artery lesions that have undergone endoluminal revascularization to achieve flow recanalization without more than 50% residual stenosis.

Exclusion Criteria:

1. 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.

3\) Patients who have been enrolled in medications that interfere with this clinical trial within the last 3 months or who have been treated intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, and so on; 4) Pregnant and lactating women 5) Patients who are unable or unwilling to participate in this trial. 6) patients with Berger's disease 7) patients who have received arterial bypass diversion on the treated side

Where this trial is running

Wuhan, Hubei

• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Zibo Feng, MD

Conditions Peripheral Artery Disease; Chronic Limb Threatening Ischemia; Severe calcification