跳至主要内容
临床试验/NCT02428582
NCT02428582Unknown不适用

Covered Stents Versus Bare-Metal Stents in Chronic Atherosclerotic Gastrointestinal Ischemia

Erasmus Medical Center2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
84
试验地点
2
主要终点
The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease.

研究概览

简要总结

To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.

详细描述

Symptomatic chronic atherosclerotic gastrointestinal ischemia (CGI) is an uncommon, potentially underdiagnosed condition caused by fixed stenosis or occlusion of in most conditions at least one of the three gastrointestinal arteries. Atherosclerosis is a predisposing factor for CGI. Clinical symptoms can vary widely. Typical symptoms are postprandial abdominal pain, unintended weight loss and food avoidance. But atypical abdominal pain such as exercise related pain, diarrhoea and nausea can also indicate CGI. The use of endovascular techniques for revascularization of chronic stenosis and occlusions of the gastrointestinal arteries has rapidly increased and endovascular therapy with stenting has become the most common method chosen for revascularization, having replaced open surgery with its associated morbidity and mortality. Nowadays standard care in significant chronic gastrointestinal ischemia is the use of bare metal stents although the patency of these stents is not very high. According retrospective data the patency of covered stents is significantly higher compared to bare metal stents. One likely explanation for these lower restenosis and re-intervention rates observed with covered stents is the established barrier to tissue ingrowth. Only recent retrospective data about this topic is available but the expectancy in this prospective study is that the patency of covered stents is indeed higher compared to metal stents.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with consensus diagnostic of CGI based on a clinical meeting with a gastroenterologist, a vascular surgeon and an interventional radiologist.
  • Diagnostic consensus of CGI is based on.
  • Presence of postprandial pain
  • Unexplained weight loss (>5% of normal body weight).
  • Significant stenosis of >50% of at least one of the gastrointestinal arteries on a recent CTA (Computer Tomographic Angiography) not older than one year, with maximum slice thickness 1 mm and enhancement in aorta of 300HU (Hounsfields Units)
  • Mucosal ischemia detected by VLS (Visible Light Spectroscopy) or tonometry
  • Patients over the age of 18 years.
  • Patients who gave informed consent.
  • Patients have sustained atherosclerosis.

排除标准

  • Patients who don't give informed consent.
  • Age < 18 years
  • No stenosis detected during arteriography.
  • Renal insufficiency (GFR below 30 ml/min or GFR below 60 ml/min when comorbidities relevant to kidney function present).
  • Previous stent placement in the to be treated gastrointestinal artery.
  • Pregnancy
  • Celiac artery compression syndrome.
  • Vasculitis

结局指标

主要结局

The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease.

时间窗: 12 to 24 months

次要结局

  • The freedom from restenosis after 6-, 12- and 24- months after stent implantation(6 to 24 month)
  • The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation(6 to 24 month)
  • The freedom from reintervention after 6-, 12- and 24- months after stent implantation(6 to 24 month)
  • The clinical outcome in terms of quality of life and therapeutic and total costs after 6-, 12- and 24- months after stent implantation(6 to 24 month)
  • The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation(6 to 24 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trialbureau radiology

Coordinating trialbureau

Erasmus Medical Center

研究点 (2)

Loading locations...

相似试验

Covered Stents Versus Bare-Metal Stents | 临床试验