Actively Recruiting
Multicenter Registry for Paclitaxel-Coated Balloon Angioplasty in Infrapopliteal Arterial Lesions (the ACT Study)
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
52 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 research aims to assess the effectiveness and safety of drug-coated balloon (DCB) angioplasty for patients with critical limb-threatening ischemia (CLTI) who have significant artery blockages below the knee. It focuses on patients with severe limb ischemia classified as Rutherford category 4 to 6 and infrapopliteal arterial lesions suitable for angioplasty. The study is observational and conducted at multiple centers to gather real-world data on this treatment approach. Participants will be treated using the AcoArt drug-coated balloon to open blocked arteries below the knee. After the initial angioplasty procedure, follow-up visits will occur at 1, 3, 6, and 12 months. These visits will collect data on wound healing, ischemia, foot infections, artery calcifications, clinical improvements, and any need for further revascularization or adverse events related to the treated artery. During the study, participants will undergo evaluations including clinical assessments of limb status and questionnaires about vascular quality of life at multiple time points. Researchers will measure outcomes such as sustained clinical improvement, freedom from major limb adverse events, patency of the treated artery, and wound healing rates over one year. Safety and effectiveness will be monitored through these scheduled follow-ups, with total participation lasting up to 12 months after the procedure.
CONDITIONS
Brief Title
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rutherford grade 4 to 6 critical limb ischemia
- Ability to understand the study purpose, volunteer, and provide informed consent
- Single or sequential new or restenotic lesions with at least 70% narrowing or occlusion in infrapopliteal arteries longer than 20 mm, not extending beyond the ankle joint
- Successful wire crossing of the lesion and restored blood flow after pre-dilation
- At least one infrapopliteal artery treated with a drug-coated balloon
- For patients with aortoiliac and femoral-popliteal artery disease, blood flow must be restored with less than 50% residual narrowing
- Patients treated with mechanical thrombectomy or catheter thrombolysis before drug-coated balloon intervention below the knee
- Patients who have previously received drug-coated balloon treatment for both lower limbs can be included based on treatment timing
- Life expectancy greater than 24 months
You will not qualify if you...
- Blood flow could not be successfully restored
- Stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or heart attack within 3 months before enrollment
- Known allergy to heparin, aspirin, antiplatelet drugs, or contrast agents
- Participation in other clinical trials involving drugs or devices interfering with this trial within 3 months
- Pregnant or breastfeeding women
- Diagnosis of Berg's disease
- Need for major amputation due to severe limb infection or ischemia based on preoperative evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo drug-coated balloon angioplasty to treat infrapopliteal arterial lesions.
1 procedure visit (in-person)
Duration - 12 months
Participants are followed to monitor wound healing, ischemia, infection, clinical improvements, and other health outcomes after the procedure.
Follow-up visits at 1 month, 3 months, 6 months, and 12 months (in-person)
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
Y
Ye Du
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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