Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Primary sustained clinical improvement at 12 months post-procedure
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford grade 4-
- •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.
排除标准
- •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
结局指标
主要结局
Primary sustained clinical improvement at 12 months post-procedure
时间窗: 12 months
Primary sustained clinical improvement was defined as an upward shift on the Rutherford classification (Appendix) to a level of intermittent claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation.
Freedom of major limb adverse events at 12 months post-procedure
时间窗: 12 months
Major limb adverse events were defined as the composite of clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and treatment caused death.
次要结局
- Amputation free survival rate(1 month, 3 months, 6 months, 12 months)
- Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional(1 month, 3 months, 6 months, 12 months)
- Vascular quality of life questionnaire(VascuQol)(1 month, 3 months, 6 months, 12 months)
- Secondary sustained clinical improvement(1 month, 3 months, 6 months, 12 months)
- Procedural success rate(72 hours)
- Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at 1 month, 3 months, 6 months, 12 months post-procedure.(1 month, 3 months, 6 months, 12 months)
- Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure.(1 month, 3 months, 6 months, 12 months)
- Primary sustained clinical improvement(1 month, 3 months, 6 months)
- Wound healing rate(1 month, 3 months, 6 months, 12 months)
研究者
Zibo Feng
Director of Vascular Surgery, Liyuan Hospital
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology