Using shockwave balloons to treat severe calcification in leg arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zibo Feng, MD
• Email: fengzibo@hust.edu.cn
• Phone: 86-13545160302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.