NL-OMON49235已完成不适用
Comparison of the Supraflex Cruz 60 micron stent strut versus the Ultimaster Tansei 80 micron stent strut in High Bleeding Risk PCI population - Compare 60/80 HBR
Research Maatschap Cardiologen Rotterdam Zuid0 个研究点目标入组 736 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
- 736
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
- •Patients are eligible for inclusion into the study if the following criteria
- •Patients of 18 years and above
- •Written or witnessed oral consent to participate in the study
- •Native coronary artery lesions eligible for PCI with stents with no
- •restrictions in number of lesions and stents, vessel size or lesion complexity,
- •apart from stent thrombosis.
- •Patients at high risk for bleeding according to the HBR ARC criteria.
- •Patients meet the HBR ARC criteria if >=1 major or >=2 minor criteria are met.
- •Major HBR criteria are the following:
- •-Clinical indication for treatment with oral anticoagulants (OAC/NOAC) for at
- •least 12 months
- •- Severe or end-stage chronic kidney failure (GFR <= 30 ml/min)
- •- Hemoglobin (Hb) level at screening < 11g/dl or < 6.8 mmol/l
- •- Spontaneous bleeding requiring hospitalization or transfusion in the past 6
- •months or at any time, if recurrent
- •- Moderate or severe baseline true thrombocytopenia (platelet count <100
- •- History of chronic bleeding diathesis, like: leukemia, haemophilia, vitamin K
- •deficiency, Factor V or VII deficiency etc.
- •- Liver cirrhosis with portal hypertension
- •- Active malignancy (other than skin) within the past 12 months
- •- Spontaneous intracranial haemorrhage ICH (at any time)
- •- Traumatic intracranial haemorrhage ICH within 12 months
- •- Presence of a brain arterio-venous malformation (AVM)
- •- Moderate or severe ischemic stroke within the past 6 months
- •- Nondeferrable major surgery on DAPT after PCI
- •- Recent major surgery or major trauma within 30 days before PCI
- •Minor HBR criteria are the following:
- •- Age >= 75 years
- •- Moderate chronic kidney disease (GFR >30 and <60 ml/min)
- •- Hemoglobin (Hb) 11-12.9 g/dL / 6.8-8.0 mmol/l for men and 11-11.9 g/dL /
- •6.8-7.4 mmol/l for women
- •- Any ischemic stroke at any time not meeting the major criterion
- •- Spontaneous bleeding requiring hospitalization or transfusion within the past
- •- Need for chronic treatment with steroids or non-steroidal anti-inflammatory
排除标准
- •Patients are not eligible if any of the following applies:
- •Treated with stents other than Supraflex Cruz or Ultimaster within 6 months
- •prior to index procedure
- •Treatment of lesions with stent thrombosis
- •Treatment of venous or arterial coronary grafts
- •Treated for stent thrombosis in 12 months prior to index PCI procedure
- •Treated with a bioresorbable scaffold 3 years before index PCI procedure
- •Cardiogenic shock at index procedure
- •Active SARS-CoV-2 infection of suspicion of SARS-CoV-2 infection
- •Cannot provide written informed consent
- •Under judicial protection, tutorship or curatorship
- •Unable to understand and follow study-related instructions or unable to
- •comply with study protocol
- •Active bleeding requiring medical attention (BARC>=2) at index PCI
- •Life expectancy less than one year
- •Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor,
- •prasugrel, cobalt chromium or sirolimus
- •Any anticipated PCI after index PCI, unless planned and scheduled at index
- •Participation in another stent or drug trial
研究者
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