Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Recruiting now

Conditions studied: Arteriosclerosis, Peripheral Artery Disease, Chronic Limb Threatening Ischemia

In brief

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).

Key facts

Study ID

NCT05620095

Run by

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

People needed

1000

Starts

2020-12-01

Expected to finish

2026-11-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnant and lactating women.
• Patients with Berg's disease.
• Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia

Where it is running

• Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Zibo Feng — Wuhan, Hubei, China (enrolling)
• the second Affiliated Hospital of Medical College of Suzhou University — Suzhou, Jiangsu, China (enrolling)
• Qingdao Haici hospital affiliated to Qingdao University — Qingdao, Shandong, China (enrolling)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Renji Hospital of Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (enrolling)
• Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, Sichuan, China (enrolling)
• Hangzhou First People's hospital of Medical College of Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
• the First Affiliated hospital of Medicine College of Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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