Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
研究概览
简要总结
This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.
详细描述
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment.
Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation.
The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •18 years or older
- •Presenting with NST-ACS
- •At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA)
- •Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation
- •The patient is willing to participate in the study
- •Target vessel suitable for OCT imaging
排除标准
- •Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3
- •Target lesion located within 5.0 mm of vessel origin
- •Severe tortuosity
- •Chronic total occlusion of the target vessel
- •Target lesion is located in or supplied by an arterial or venous bypass graft.
- •Impaired renal function (eGFR <30ml/min) *
- •Pregnant or breastfeeding patients *
- •Patient has a known allergy to contrast medium *
- •Contraindication for the use of nitrates *
- •Life expectancy <12 months
结局指标
主要结局
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
时间窗: 0 days
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
次要结局
- The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI(0 days)
- The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI(0 days)
- Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI(0 days)
- Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI(0 days)
研究者
Joost Daemen
Interventional Cardiologist
Erasmus Medical Center