Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

Blood flow was not successfully reestablished.

Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.

Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.

Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.

Trial design

Treatments tested in this trial

  • drug-coated balloon

Treatment groups

No treatment groups listed

Locations

10
Xuanwu Hospital Capital Medical University BeijingBeijing Municipality, China
Zibo Feng430000, WuhanHubei, China
the second Affiliated Hospital of Medical College of Suzhou University SuzhouJiangsu, China
Qingdao Haici hospital affiliated to Qingdao University QingdaoShandong, China

Sponsors and collaborators

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Xuanwu Hospital, Beijing

Collaborator

RenJi Hospital

Collaborator

Zhejiang University

Collaborator

First People's Hospital of Hangzhou

Collaborator

Second Affiliated Hospital of Suzhou University

Collaborator

Qingdao University

Collaborator

Chengdu University of Traditional Chinese Medicine

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Huashan Hospital

Collaborator

Source ClinicalTrials.gov