LiquID Guide Catheter Extension Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
研究概览
简要总结
Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension
详细描述
The study will consist of evaluating the safety and performance of the LiquID Guide Catheter Extension (GCE) compared to historical data. The safety measures will consist of procedural Major Adverse Cardiac Events (MACE) while performance measures will include Device Oriented Clinical Outcomes.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants must be:
- •scheduled for non-emergent, percutaneous coronary procedure in which the use of a guide catheter extension is anticipated
- •able to provide informed consent to participate in the study
排除标准
- •participants must not have:
- •evidence of ongoing ST-elevation myocardial infarction (STEMI) or STEMI treatment for late presentation STEMI with index admission (stabilized acute coronary syndrome allowed)
- •left ventricular ejection fraction <20%
- •required intervention in a saphenous vein graft
- •an intolerance or known allergy to medications/contrast expected to be used during the procedure or during hospital stay
- •had a cardiac intervention within two weeks of the procedure
- •renal insufficiency (serum creatinine of > 2.3 mg/dl)
- •active gastrointestinal bleeding
- •an active infection or fever (>37.8º C) that may be due to infection
- •significant anemia (hemoglobin < 8.0 mg / dl)
- •severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the past month)
- •a severe electrolyte imbalance
- •congestive heart failure (NYHA Class IV)
- •presented with an acute coronary syndrome where serum troponin concentrations have not been demonstrated to be declining prior to the scheduled procedure (within the past two weeks)
- •uncontrolled diabetes (> 2 serum glucose concentrations of > 350 mg/dl within the past 7 days)
- •participation in an investigational protocol
- •unwillingness or inability to comply with any protocol requirements
- •angina, or ischemia caused by occluded artery
- •other clinical conditions, that in the opinion of the investigator significantly compromise the ability to perform a safe and/or effective procedure
- •Vulnerable Population Exclusion - participants must not be:
- •under 18 years old
- •pregnant or nursing
- •immuno-compromised
- •over 89 years old
- •incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent (including emergency situations)
结局指标
主要结局
The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
时间窗: 48 hours or discharge (whichever comes first)
* Device-caused events including: * Target vessel dissection * Longitudinal stent deformation * Proximal collar stent stripping * Cardiac death * Stroke * Peri-procedural myocardial infarction (MI) based on participant symptoms, ECG changes and/or SCAI definition (if cardiac enzymes are available)
次要结局
- The Number of Participants With Device Oriented Clinical Outcome(1 Day)