Actively Recruiting
Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries
Led by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-12-03
130
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of shockwave balloons to treat moderate-to-severe calcification in the femoropopliteal artery, a condition common among patients with peripheral artery disease (PAD) and associated with diabetes or chronic kidney disease. This study aims to assess the real-world effectiveness of shockwave balloons in managing calcified lesions, building on previous trials that showed promising results but lacked extensive real-world data. The study evaluates the Shockwave intravascular lithotripsy (IVL) catheter system, which is designed to break down calcified structures in arteries while minimizing damage to the vessel lining. The device is used during angioplasty procedures to improve artery opening. Patients with moderate-to-severe calcification confirmed by imaging will be treated, and the study collects data on outcomes such as procedural success, patency rates, need for additional stenting, and safety over a follow-up period extending up to 12 months. Participants will undergo assessments including imaging to confirm lesion severity and arterial flow, along with clinical evaluations over several months after treatment to monitor improvement and adverse events. Researchers will track the quality of life related to vascular health and the rate of revascularization procedures at multiple timepoints. The study is observational, focusing on data collection from real-world use of the shockwave balloon technology, with participation lasting at least one year for outcome follow-up.
CONDITIONS
Brief Title
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Rutherford Classification 2-5
- More than 70% stenosis or occlusion of the femoropopliteal artery confirmed by digital subtraction angiography
- At least one healthy patent outflow tract distal to the knee continuous with a patent outflow tract below the ankle
- Ability to understand the study purpose, voluntary participation, and signed informed consent
- Guidewire can pass through the lesion
- Life expectancy greater than 24 months
- Moderately severe calcified lesions confirmed by imaging
- For patients with interventions in both legs, enrollment is based on the timing of intracavitary treatment
- Combined aortoiliac artery lesions previously treated with flow recanalization and less than 50% residual stenosis
You will not qualify if you...
- Stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or heart attack within 3 months before enrollment
- Known allergy to heparin, aspirin, other antiplatelet drugs, or contrast agents
- Use of medications interfering with the trial or use of special vascular bed devices within the last 3 months
- Pregnant or breastfeeding women
- Unable or unwilling to participate in the trial
- Diagnosis of Berger's disease
- Previous arterial bypass surgery on the treated side
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive angioplasty treatment using the Shockwave intravascular lithotripsy catheter system for severe calcified lesions in the femoropopliteal arteries.
1 procedural visit (in-person)
Duration - Up to 12 months
Participants are monitored over time to assess the effectiveness and safety of the treatment, including clinical improvement and freedom from target lesion revascularization.
Follow-up visits at 1 month, 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
Z
Zibo Feng, MD
Y
Ye Du, DM
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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