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