跳至主要内容
临床试验/NL-OMON41499
NL-OMON41499已完成不适用

DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents. A prospective, randomized, controlled, triple-blind, multi-center trial comparing PTFE-covered balloon-expandable stents versus uncovered balloon-expandable stents in patients with advanced occlusive disease of the common iliac artery in terms of morphologic, clinical, and hemodynamic outcome after a 2-year follow-up. - Covered versus uncovered balloon-expandable iliac stents.

Maasstadziekenhuis0 个研究点目标入组 174 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
174

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Age over 18
  • - Symptomatic, atherosclerotic lesion of the common iliac artery, either a hemodynamically significant stenosis with a length of more than 3 cm, or an occlusion
  • - Signed informed consent form

排除标准

  • - Stenosis with a length of less than 3 cm
  • - Presence of a metastatic malignancy, or other disease that limits life expectancy to less than two years.
  • - Previous endovascular or surgical treatment of the common iliac artery on the affected side.
  • - Inability or unwillingness to comply with the follow-up schedule.
  • - Mental disability or language barrier that hinders the ability to understand and comply with the informed consent.
  • - Pregnancy or breast-feeding.
  • - Severe renal failure (e-GFR <30 mL/min/1.73 m2)
  • - Known allergy to iodinated contrast agents or to PTFE.
  • - Contra-indication for anti-coagulation.
  • - Acute limb ischemia
  • - Occlusion of the abdominal aorta
  • - Aneurysm of the abdominal aorta that is not amenable to endograft placement

研究者

发起方
Maasstadziekenhuis

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