Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLiyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
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
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