Actively Recruiting
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
Led by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-03-25
1000
Participants Needed
10
Research Sites
308 weeks
Total Duration
On this page
Sponsors
L
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).
CONDITIONS
Official Title
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rutherford grade 4 to 6
- Understands the study purpose, agrees to participate, signs informed consent, and is willing to follow up
- Single or sequential new or recurrent lesions with 70% or more narrowing or blockage in infrapopliteal arteries longer than 20 mm, not extending beyond the ankle joint
- Successful wire crossing of the lesion and continuous blood flow after pre-dilation
- At least one infrapopliteal artery treated with a drug-coated balloon
- For patients with disease in other leg arteries, blood flow must be restored with no more than 50% narrowing remaining
- Patients with lower extremity arterial thrombosis treated with thrombectomy or catheter thrombolysis and drug balloon intervention below the knee
- Patients who have had drug-coated balloon treatment in both lower limbs can be included based on treatment timing
- Life expectancy greater than 24 months
You will not qualify if you...
- Blood flow was not successfully restored
- Stroke, cerebral hemorrhage, gastrointestinal bleeding, or heart attack within 3 months before enrollment
- Known allergy to heparin, aspirin, other antiplatelet drugs, or contrast agents
- Participation in other drug or device clinical trials interfering with this study within the past 3 months
- Pregnant or breastfeeding women
- Patients with Berg's disease
- Patients needing major amputation due to severe limb infection or ischemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Zibo Feng
Wuhan, Hubei, China, 430000
Actively Recruiting
3
the second Affiliated Hospital of Medical College of Suzhou University
Suzhou, Jiangsu, China
Actively Recruiting
4
Qingdao Haici hospital affiliated to Qingdao University
Qingdao, Shandong, China
Actively Recruiting
5
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
6
Renji Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Actively Recruiting
7
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
8
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Actively Recruiting
9
Hangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
10
the First Affiliated hospital of Medicine College of Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
Zibo Feng
CONTACT
Y
Ye Du
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
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