Drug-coated balloon angioplasty for below the knee arterial lesions

Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)

This study is testing whether a special drug-coated balloon treatment can help people with severe leg circulation problems heal better and avoid complications.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT05620095 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with Rutherford grade 4-5 critical limb ischemia and significant infrapopliteal lesions suitable for angioplasty.

Not a fit: Patients with lesions extending beyond the ankle joint or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve limb preservation and quality of life for patients with critical limb ischemia.

How similar studies have performed: Other studies have shown promising results with drug-coated balloon angioplasty in similar patient populations, indicating a potential for success.

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 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 this trial is running

Beijing, Beijing Municipality and 9 other locations

• 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)
• Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, Sichuan, China (Recruiting)
• Hangzhou First People's hospital of Medical College of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• the First Affiliated hospital of Medicine College of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Zibo Feng — Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Zibo Feng

Conditions Arteriosclerosis; Peripheral Artery Disease; Chronic Limb Threatening Ischemia; Drug-coated Balloon; Angioplasty; Below the knee