A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major adverse events
研究概览
简要总结
This study is a prospective, multicenter real-world observational study to understand the safety and efficacy of endoluminal therapy and traditional endometristomy in the real world for patients with severe stenosis and occlusion of the common femoral artery. The study will enroll 300 patients with severe stenosis and occlusion of chronic common femoral artery in nine centers across the country. According to the different intervention methods of the common femoral artery, the enrolled cases were divided into two groups: A: endometrial detachment for common femoral artery lesions and B: interventional endovascular treatment for common femoral artery lesions. As it is a real-world study, there is no separate primary endpoint indicator, which mainly observes F-TLR (immunity from vascular re-intervention), technical success rate, duration of surgery, length of hospital stay, common femoral artery patency rate, deep femoral artery patency rate, direct and indirect medical expenditure associated with the disease in 24 months, MAE (major adverse events), and perioperative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Patients with chronic atherosclerotic occlusion who are over 18 years old;
- •Patients with Rutherford clinical grading range in the range of 2-5;
- •The stenosis rate of the common femoral artery (including the bifurcation of the femoral artery) is > 60% or occlusive, and it is proposed to undergo intraluminal treatment such as balloon dilation, stent implantation, plaque rotation and excision, or endometrial decortication treatment;
- •At least one healthy sub-knee outflow tract (or opened through reconstruction) communicates with the blood vessels of the foot;
- •Intravascular treatment: the guide wire successfully passed through the target lesion;
- •For patients with combined aorta iliac artery lesions, after completing the reconstruction of the main iliac artery, they can be enrolled according to the above requirements; except for the ipsilateral iliac artery, other non-target lesions of the remaining non-target blood vessels can be treated by the doctor at his own discretion;
- •For patients with both lower limbs that meet the admission conditions, both limbs can be enrolled separately in chronological order;
- •Written informed consent prior to the study procedure.
排除标准
- •Patients who are unwilling or refuse to sign informed consent;
- •Known or suspected allergy or contraindications to aspirin, clopidogrel bisulfate, heparin or contrast agents;
- •Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 onths;
- •pregnant and lactating women;
- •Life expectancy is less than 24 months;
- •Patients whose common femoral artery has received endometrial detachment, plaque rotation, stent implantation and restenosis in stents;
- •Patients with acute ischemia of grade III lower extremities who have lost the opportunity for vascular reconstruction;
- •Any major medical condition that the researchers believe may affect the subject's optimal participation in the study.
结局指标
主要结局
Major adverse events
时间窗: post-interventional 30days
Major adverse events at 30days
freedom from target lesion revascularization
时间窗: post-interventional 2 years
freedom from target lesion revascularization at 2years
次要结局
- Perioperative complications(post-interventional 30days)
- Direct and indirect medical expenditures associated with the disease(post-hospitalization 24 months)
- Time of surgery(post-intervention)
- Time of hospital stay(post-hospitalization)
- freedom from target lesion revascularization(post-interventional 1,3,6, 9,12 month)
- primary patency of CFA(post-interventional 1,3,6, 9,12 and 24 month)
- primary patency of PFA(post-interventional 1,3,6, 9,12 and 24 month)
- Technical success rate(post-intervention)