Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
Launched by LIYUAN HOSPITAL OF TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Nov 27, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the use of a special balloon treatment called the Shockwave IVL Catheter System for patients with Peripheral Artery Disease (PAD), specifically those who have serious calcium buildup in the femoral popliteal artery. The goal is to see how well this new treatment works in real-life situations, as there hasn’t been enough research done on it yet. The trial is currently recruiting participants who are at least 18 years old and have significant narrowing or blockage in their artery, confirmed by imaging tests.
To participate, individuals should be willing to sign consent and understand the study's purpose. They should also have a life expectancy of more than two years and have at least one healthy artery below the knee. However, those with recent serious health issues, allergies to certain medications, or specific medical conditions may not be eligible. Participants in this trial can expect to receive careful monitoring and follow-up during the study to assess how well the treatment works for them.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • -
- • 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
About Liyuan Hospital Of Tongji Medical College, Huazhong University Of Science And Technology
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, is a leading clinical research institution dedicated to advancing medical knowledge and improving patient outcomes through innovative studies. As a prominent academic hospital, it leverages its affiliation with a prestigious university to foster a collaborative research environment, integrating clinical expertise with cutting-edge scientific inquiry. The institution is committed to conducting high-quality clinical trials across various therapeutic areas, ensuring adherence to rigorous ethical standards and regulatory guidelines. With a focus on patient care and safety, Liyuan Hospital aims to contribute significantly to the development of new therapies and enhance the overall healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wuhan, Hubei, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported