Prospective Randomized Clinical Trial of the Remote Endarterectomy and the Femoral Arteries Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease (TASC C, D)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- the change of lumen in target vessel
研究概览
简要总结
Comparison of two methods for revascularization of the superficial femoral artery: remote endarterectomy vs. stenting of the superficial femoral artery cin patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D
详细描述
Reported local percutaneous angioplasty and stenosis of femoral popliteal arteries indicate that the primary technical and clinical success above 95%. The technical success of recanalization of long occlusions femoral arteries less than 80%. Improvement of endovascular equipment designed for the treatment of total occlusions, increases the technical success of recanalization. The materials of the TASC II summarizes the results of several large studies that presented data on the operated segment artery patency at 56-73,7% within 2 years of observation. An alternative method of revascularization own femoral artery is remote endarterectomy. The two-year primary patency at remote endarterectomy is 86% (Moll F.L., Iio G.H. Closed superficial femoral artery endarterectomy: a 2-year follow up. Cardiovasc Surg. 1997; 5: 398-400). Primary assisted patency for 33 months 88% (Rosenthal D, Martin JD, Schubart PJ, Wellons ED. Remote. superficial femoral artery endarterectomy. J Cardiovasc Surg. (Torino) 2004; 45: 185-192). The length of the occlusion is not a limitation to the use of remote endarterectomy. Primary patency at 31 months was 60%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 occlusive lesions of C and D type femoral artery and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford)
- •Patients who consented to participate in this study.
排除标准
- •Chronic heart failure of III-IV functional class by NYHA classification.
- •Decompensated chronic "pulmonary" heart
- •Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- •Polyvalent drug allergy
- •Cancer in the terminal stage with a life expectancy less than 6 months;
- •Acute ischemic
- •Expressed aortic calcification tolerant to angioplasty
- •Patients with significant common femoral artery lesion
- •Patient refusal to participate or continue to participate in the study
结局指标
主要结局
the change of lumen in target vessel
时间窗: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
次要结局
- Number of participants with a successful procedure of revascularization.(During the operation.)
- Number of participants with complications during the operation.(During the operation.)
- Number of participants with limb salvage(Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years)