NCT02919943已完成不适用
Impact of Angiographic Coregistered Optical Coherence Tomography-diagnostics on Physicians Decision-making During Percutaneous Coronary Intervention in Patients With Advanced Coronary Artery Disease - the "OPTICO-Integration-Trial"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone
研究概览
简要总结
To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Patient provides signed written informed consent before any study-specific procedure.
- •Patients suffer from coronary artery disease (CAD) including at least one angiographically significant (>70% visual estimation) stenosis present in a native coronary artery with planned PCI.
排除标准
- •Subjects with emergent PCI or in cardiogenic shock.
- •Subjects with target left main (LM) lesion, with restenosis or stent thrombosis in the target vessel or with aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- •Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion.
- •Known renal insufficiency (examples being but not limited to estimated glomerular Filtration rate (eGFR) < 50 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL or on dialysis).
- •Any other medical condition that in the opinion of the investigator will interfere with patients safety or study results.
- •Currently participating in another clinical study that interferes with study results.
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- •Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy
结局指标
主要结局
The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone
时间窗: 20 months
次要结局
- Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone.(20 months)
- Longitudinal geographical miss (GM) with uncovered residual parts of "target lesion" at the proximal or distal reference segment of the stent. Detected by comparison between pre-PCI OCT with post-PCI OCT.(20 months)
- Rate of side branch occlusions (%).(20 months)
- Strategy changes based on post-procedural OCT and ACR Imaging.(20 months)
- Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment.(30 days, 6 months, and 12 months.)
研究者
David Manuel Leistner
PD M.D.
Charite University, Berlin, Germany
研究点 (1)
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