Actively Recruiting
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
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
204 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
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level. Therefore, in this study, we wish to set up a real-world study of shockwave balloon in the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloon in the treatment of moderate-to-severe calcified lesions.
CONDITIONS
Official 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% narrowing or blockage of the femoropopliteal artery confirmed by imaging
- One healthy patent outflow tract below the knee continuing to a patent outflow tract below the ankle
- Understands the study purpose, voluntarily consents, and agrees to follow-up
- Guidewire can pass through the lesion
- Life expectancy greater than 24 months
- Moderate to severe calcified lesions confirmed by imaging
- Patients receiving treatment in both legs may enroll based on treatment timing
- For combined aortoiliac artery lesions, prior successful revascularization with less than 50% residual narrowing
You will not qualify if you...
- Stroke, cerebral hemorrhage, gastrointestinal bleeding, or heart attack within 3 months before enrollment
- Known allergy to heparin, aspirin, other antiplatelet drugs, or contrast agents
- Use of interfering medications or special vascular devices within past 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 leg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Ye Du, DM
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here