Drug-coated balloon angioplasty for below the knee arterial lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study evaluates the effectiveness and safety of drug-coated balloon (DCB) angioplasty in patients with critical limb ischemia (Rutherford category 4-5) and significant infrapopliteal lesions. Participants will undergo treatment with the AcoArt drug-coated balloon, followed by follow-up assessments at 1, 3, 6, and 12 months post-procedure. Data collected will include wound healing, ischemia, foot infection, clinical improvements, and major adverse events. The study aims to provide insights into the long-term outcomes of this intervention in a critical patient population.

Why it matters

Who can join: the full rules

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 knee arterial drug balloon intervention.
8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
9. Life expectancy\> 24 months.

Exclusion Criteria:

1. Blood flow was not successfully reestablished.
2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
5. Pregnant and lactating women.
6. Patients with Berg's disease.
7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia

Where it's running

• Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Zibo Feng
  Wuhan, Hubei, China Recruiting
• the second Affiliated Hospital of Medical College of Suzhou University
  Suzhou, Jiangsu, China Recruiting
• Qingdao Haici hospital affiliated to Qingdao University
  Qingdao, Shandong, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Renji Hospital of Shanghai Jiaotong University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zibo Feng — Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Zibo Feng
• Email: fengzibo@hust.edu.cn
• Phone: 86-13545160302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.