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Recruiting NCT05620095

Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Trial Parameters

Condition Arteriosclerosis
Sponsor Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-12-01
Completion 2025-11-01
Interventions
drug-coated balloon

Brief 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).

Eligibility Criteria

Inclusion Criteria: 1. Rutherford grade 4-6. 2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up. 3. 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. 4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow. 5. At least one of the infrapopliteal arteries received a drug-coated balloon. 6. 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%. 7. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the kne

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