Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
Key facts
- Where
- Beijing, Chengdu, Hangzhou, Qingdao, Shanghai, Suzhou, and Wuhan, ChinaSee the 10 sites
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Lianrui GuoTaking people
- Hospital of Chengdu University of Traditional Chinese MedicineChengdu, ChinaContact: Chunshui HeTaking people
- Hangzhou First People's hospital of Medical College of Zhejiang UniversityHangzhou, ChinaContact: Xin FangTaking people
- the First Affiliated hospital of Medicine College of Zhejiang UniversityHangzhou, ChinaContact: Ziheng WuTaking people
- Qingdao Haici hospital affiliated to Qingdao UniversityQingdao, ChinaContact: Qiang LiTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaContact: Weihao ShiTaking people
- Renji Hospital of Shanghai Jiaotong UniversityShanghai, ChinaContact: Meng YeTaking people
- Zhongshan Hospital of Fudan UniversityShanghai, ChinaContact: Zhenyu ShiTaking people
- the second Affiliated Hospital of Medical College of Suzhou UniversitySuzhou, ChinaContact: Hongfei SangTaking people
- Zibo FengWuhan, ChinaContact: Zibo FengTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT05620095
- Record updated
- 25 March 2026
- Original description
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).Read full original descriptionShow less
Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)
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).
Inclusion: Rutherford grade 4-6; Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up; Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries >20 mm. Lesions should not extend beyond the ankle joint; Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow; At least one of the infrapopliteal arteries received a drug-coated balloon; For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%; In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention; Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time; Life expectancy> 24 months.
Exclusion: Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment; Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months; Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc; Patients with Berg's disease; Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia; Blood flow was not successfully reestablished; Pregnant and lactating women.