Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- MACNE (Major Adverse Cardiac or Neurological Event )
研究概览
简要总结
The main objective of the IMS-Study is to evaluate the short and long-term safety and efficacy of mesh stent implantation in patients with stenotic iliac disease with complex plaques or lesions containing thrombotic material.
详细描述
Iliac artery disease may include complex lesions with a vulnerable plaque and containing thrombotic materials. The treatment of these complex plaques is frequently complicated with local, acute occlusion, dissection and distal embolisation.
Studies with a mesh stent in the carotid region have shown a reduced risk of peripheral embolization. The use of mesh stents in iliac arteries can provide similar benefits. The structure of the stents, sizes, and the release system do not require any changes. The study is to assess the usefulness of mesh stents in preventing peripheral embolisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •General Inclusion Criteria (principal):
- •Patients older than 18 years, after Vascular Team evaluation, according to local standards, eligible for Iliac artery
- •Written, informed consent to participate
- •Agreement to attend Protocol required (standard) follow up visits and examinations
- •Angiographic Inclusion Criteria (principal):
- •De novo iliac stenosis
- •Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines)
- •High-risk morphology stenosis with complex/thrombotic lesions (per 1 independent, experienced operator).
排除标准
- •General Exclusion Criteria (principal):
- •Life expectancy <1 year (e.g., active neoplastic disease).
- •Chronic kidney disease with creatinine > 3.0 mg/dL.
- •Coagulopathy.
- •Contraindication for decoagulation
- •History of uncontrolled contrast media intolerance
- •Myocardial infarction in 72 hours preceding the stenting procedure (if possible, postponing the procedure)
- •Stroke in 6 weeks preceding the stenting procedure (if possible, postponing the procedure)
- •Pregnancy (positive pregnancy test)
- •AngiographicExclusion Criteria (principal):
- •Chronic total occlusion not amenable to re-canalization
- •Stent in the target vessel/lesion
- •Anatomic variants precluding stent implantation
- •Mobile (free-floating) plaque elements in aorta or arteries proximal to the target lesion
结局指标
主要结局
MACNE (Major Adverse Cardiac or Neurological Event )
时间窗: 48 hours after procedure
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
次要结局
未报告次要终点