Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 40
- 主要终点
- Freedom from restenosis,
研究概览
简要总结
Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. It is a frequent pathology which affects preferentially the elderly patients of female sex (70%) with cardio-vascular comorbidities. Risk factors include smoking, hypertension, and dyslipidemia.
Despite medical and diagnostic advances, the morbidity and mortality of CMI remain very high (>70%). Optimal management of CMI is based on early diagnosis. Symptomatic patients with CMI should be treated without much delay to relief symptoms (present in 43% patients) and prevent acute mesenteric ischemia.
The three visceral arteries affected by atherosclerotic disease are coeliac trunc, inferior mesenteric artery and Superior Mesenteric Artery (SMA). The SMA is treated the most frequently, because it is the main relevant artery associated with CMI.
Endovascular treatment (angioplasty and stenting) is considered as the first-line treatment for CMI when feasible. It is indicated especially in the case of high grade stenosis or occlusion of the Superior Mesenteric Artery. Two types of stents can be used for this procedure: bare metal stents (BMS) or covered stents (CS).
Even if BMS are standard care there is no consensus on the type of stent to use.
There are very few reported series with large numbers of patients comparing BMS and CS in this indication. However, to our knowledge, no results from a randomized study addressing this issue have ever been published. These are only retrospective with a low level of evidence (IIb). The largest series compared 147 patients with primary intervention for CMI treatment using BMS versus 42 using CS. Treatment with CS showed better results in terms of symptom recurrence (10% vs 32%, p <0.002), restenosis (12% vs 42%, p <0.0002) and re-interventions (10% vs 42%), after at least 1 year of follow-up. Indeed, endovascular treatment using BMS was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels.
There are no international guidelines to recommend the use of one or another sort of stent.
The necessity of a randomised study addressing the issue of bare metal versus covered stents deployment seems to be important.
The investigators propose to demonstrate that covered stents presents a better efficacy than bare metal stents, with a multicenter randomized study involving 24 vascular surgical departments of French University Hospitals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older;
- •Diagnosis of chronic atherosclerotic mesenteric ischemia or atherosclerosis threatening disorders of digestive perfusion, with stenosis or occlusion of the superior mesenteric artery;
- •For whom a primary endovascular intervention by percutaneous transluminal angioplasty using stents has been scheduled (anatomical evaluation, arterial evaluation consistent with endovascular treatment);
- •For an ostial or post-ostial stenotic arterial lesion to be treated by only one type of stent authorized in the study according to randomization;
- •Having signed an informed consent for participation in the study.
排除标准
- •Acute mesenteric ischemia;
- •Previous revascularisation intervention for chronic mesenteric ischemia;
- •For some stenotic arterial lesion to be treated more than one type of stent;
- •Chronic renal failure (glomerular filtration rate less than 20 mL per minute);
- •Low probability of cooperation of the participant (judged by the investigator);
- •Medical or surgical history judged by the investigator to be not compatible with this study;
- •Adult ward or court (under guardianship or trusteeship);
- •Pregnant or lactating woman;
- •Person under judicial protection;
- •Subject participating in another study having an exclusion period still active.
结局指标
主要结局
Freedom from restenosis,
时间窗: 24 months after the primary endovascular treatment
Freedom from restenosis will be defined as ≥50% luminal reduction and/or thrombosis, confirmed by CT-scan. The crude percentage of restenosis and/or thrombosis at 24 months will be computed for each group. The survival curves for freedom from restenosis and/or thrombosis will be plotted according to the Kaplan-Meier method and overall survival rates will be estimated.
次要结局
- Occurrence of endovascular procedure complications(up to discharge from hospital)
- Freedom of reintervention (endovascular or surgical)(24 months after the primary endovascular treatment)
- Quality of life score(12 months after the primary endovascular treatment)
- Number of patients with maintained primary, primary assisted and secondary patencies(18 months after the primary endovascular treatment)
- Freedom of symptoms recurrence(24 months after the primary endovascular treatment)
- Occurrence of major morbidity(24 months after the primary endovascular treatment)
- Target lesion revascularisation (TLR)(24 months after the primary endovascular treatment)
- Freedom from restenosis(12 months after the primary endovascular treatment)