Overview
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).
Description
Patients with critical limb ischemia (Rutherford category 4-5) and significant infrapopliteal lesions appropriate for angioplasty will be enrolled in this study. Subjects will be treated with the AcoArt drug coated balloon, then follow-up will be conducted at 1, 3, 6, 12 months after index procedure. Data on wound, ischemia, foot infection (WIfI) calcifications, clinical improvements, wound healing, freedom form target- lesion revascularization, patency of the target lesion and major adverse events will be collected.
Eligibility
Inclusion Criteria:
- Rutherford grade 4-5.
- 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.
Exclusion Criteria:
- 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