NL-OMON34428尚未招募不适用
A Study To Evaluate The Safety And Feasibility Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel Intervention - Safety And Feasibility Of PICSO
Miracor medical systems0 个研究点目标入组 10 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
- 尚未招募
- 发起方
- 入组人数
- 10
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
- •- Subjects at least 18 years of Age
- •- Stable patient
- •- Left Anterior Descending (LAD) Stenosis as assessed by angiography
- •- Able to understand content of and willing to provide written informed consent
排除标准
- •- Active and/or treated malignancies within 12 months prior to first Visit
- •- Anatomical Complications (e.g. The system is not able to effectively occlude the coronary sinus)
- •- Presence of significant collateral flow supplying the target vessel (Rentrop 2,3)
- •- Any significant systemic illness or medical condition that could lead to difficulty complying with the protocol; or any concurrent condition(s) which, in the investigator's opinion, would prohibit the subject from completing the study, or in which case the study would not be in the best interest of the subject.
- •- Bleeding or perforation during PCI, pericardial effusion and/or hematoma
- •- Cardiac arrest or arrythmia requiring chest compressions or cardiopulmonary resuscitation
- •- Cardiogenic shock (Cardiac index <1.8 L/min/m² or assessed by the investigator), pulmonary edema (Killip Class >2), or hemodynamic instability as assessed by the investigator at the time of cardiac catheterization.
- •- Clinically significant renal disturbance (sMDRD calculated GFR *30mL/min/1,73m²)
- •- Coronary Sinus electrode in place
- •- Acute ST elevation myocardial infarction
- •- Previous Q-wave myocardial infarction within 72 hours prior to screening
- •- Ejection Fraction <20%
- •- History of stroke, any sequelea of a transient ischemic attack (TIA) or reversible ischemic neurological defect (RIND) within 6 months prior to screening
- •- left bundle branch block
- •- mitral regurgitation (MR) > grade I
- •- mitral stenosis
- •- Patient not currently in sinus rythm
- •- patients on cardiac resynchronization therapy (CRT) or scheduled for CRT implantation
- •- Patients with previous CABG or planned chronic total occlusion revascularization
- •- Pregnancy or active breast-feeding. Urine pregnancy tests will be performed on all women who are not post-menopausal for at least 1 year.
- •- registration in another interventional study
- •- severe anemia at baseline (hemoglobin <10 g/dl or <6.2 mmol/l)
研究者
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