Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Launched by LIYUAN HOSPITAL OF TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Nov 9, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called drug-coated balloon angioplasty for patients with serious circulation problems in their legs due to conditions like arteriosclerosis and peripheral artery disease. The trial aims to find out how effective and safe this treatment is for patients who have severe symptoms, known as Chronic Limb Threatening Ischemia (CLTI), which can lead to pain and even the risk of amputation if not treated. The study is currently recruiting participants aged 65 to 74 who have significant blockages in the arteries below the knee.

To be eligible for the trial, participants need to have certain conditions, such as specific grades of leg pain and blockages in their arteries that meet the study's criteria. They must also be able to understand the study and agree to participate. Those who join can expect to receive the drug-coated balloon treatment, and their progress will be monitored over time. It's essential to note that individuals with recent severe medical events, certain allergies, or who are pregnant cannot participate. This trial is an important step in understanding new ways to help improve blood flow in patients with critical leg issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Rutherford grade 4-5.
• • 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