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Clinical Trial Summary

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).


Clinical Trial Description

Patients with critical limb ischemia (Rutherford category 4-5) and significant infrapopliteal lesions appropriate for angioplasty will be enrolled in this study. Subjects will be treated with the AcoArt drug coated balloon, then follow-up will be conducted at 1, 3, 6, 12 months after index procedure. Data on wound, ischemia, foot infection (WIfI) calcifications, clinical improvements, wound healing, freedom form target- lesion revascularization, patency of the target lesion and major adverse events will be collected. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05620095
Study type Observational [Patient Registry]
Source Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Contact Zibo Feng
Phone 86-13545160302
Email fengzibo@hust.edu.cn
Status Recruiting
Phase
Start date December 1, 2020
Completion date November 1, 2026

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