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
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