Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia
- •Rutherford classification category 3-5 chronic limb ischemia,
- •age: 45-75 years old.
- •Patients who consented to participate in this study.
排除标准
- •Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis;
- •Flush occlusion of the common iliac artery;
- •Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis >50%);
- •Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis >50%);
- •Refusal to participate in the study;
- •Stroke or myocardial infarction within the past 3 months;
- •Ischemic heart disease with New York Heart Association functional class IV;
- •Malignant tumor with an estimated life span of under 6 months;
- •Previous ipsilateral or contralateral surgery (bypass, hybrid or stenting);
- •Hepatic or renal insufficiency (bilirubin> 35 mmol/l, glomerular filtration rate <60 ml/min/1.73 m2);
- •Severe calcification of the aorta and iliac arteries intolerant to balloon angioplasty (as determined by the Peripheral Arterial Calcification Scoring System on computed tomography angiography as interpreted by a vascular radiologist):12
- •unilateral calcification ≥ 5cm (Grade 2), bilateral calcification ≥ 5cm (Grade 4) or circumferential calcification , defined as 270°-360° around the circumference of aorta and/or iliac arteries.
研究组 & 干预措施
Group 1
Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
干预措施: Aorta-femoral bypass (Procedure)
Group 2
Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
干预措施: Recanalization and stenting of aorta-iliac segment (Procedure)
结局指标
主要结局
Technical success
时间窗: 1 day
Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%
30-day complication rate
时间窗: 30 days
clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism
30-day primary patency rates
时间窗: 30 days
during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.
30-day secondary patency rates
时间窗: 30-day
during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment after reintervention due to thrombosis
次要结局
- Limb salvage(36 months)
- Primary patency rates(36 months)
- Major adverse cardiovascular event (MACE)(36 months)
- Amputation-free survival(36 months)
- Secondary patency rates(36 months)