Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 3,000
- 试验地点
- 25
- 主要终点
- Combined endpoint of major adverse cardiac events (MACE)
研究概览
简要总结
The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS
详细描述
Patients presenting with acute coronary syndrome (ACS) have worse short and mid-term prognosis compared with patients revascularized for chronic coronary syndrome. Angiographic assessment of patients with ACS is frequently limited by high ambiguity both in identification of culprit lesions, characterization of non-culprit lesions, and in identification of suboptimal treatment results. Intravascular imaging may improve diagnosis and allow for better treatment optimization during coronary intervention of patients with ACS. The large-scale Chinese IVUS-ACS trial showed a 50% reduction in one-year MACE with IVUS-guided PCI in patients with ACS whereas a number of small studies on routine OCT guiding as well as ACS subgroups in RCTs did not indicate a potential similar benefit with OCT. OCT assessment has several theoretical advantages over IVUS in patients with ACS indicating the need for a well-designed strategy trial on OCT vs angiographic guided PCI.
Hypothesis
Routine OCT-guided diagnosis and revascularization yields superior one-year clinical outcome compared with standard angiography-guided diagnosis and revascularization in patients with acute coronary syndrome Methods: Investigator initiated, open label, prospective, 1:1 randomized, multi-center, clinical outcome, superiority trial.
Primary Endpoint: Major adverse cardiac events (MACE) comprising all-cause death, spontaneous myocardial infarction and stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Clinical inclusion criteria:
- •NSTEMI, STEMI
- •Symptom duration <12h for STEMI and <48h for NSTEMI
- •Age ≥ 18yrs
- •Ability to provide written informed consent
- •Angiographic inclusion criteria:
- •Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis
- •Wire in true distal lumen
排除标准
- •Clinical exclusion criteria
- •Intravascular imaging evaluation of any lesions at index procedure
- •Cardiogenic shock
- •Sustained ventricular tachycardia or ventricular fibrillation
- •Planned CABG
- •Life expectancy <1 year
- •Known severe heart failure with NYHA class equal or above III
- •Known ejection fraction <30% before the admission
- •Known renal failure with GFR <30 ml/min/1.73 m2
- •Active bleeding or coagulopathy
- •Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus)
- •Suspected inability to lie flat for the duration of the PCI procedure
- •Inability to comply with the planned follow-up program
- •Known or anticipated compliance problems with medical therapy
- •Angiographic exclusion criteria
- •Study lesion involving the Left main coronary artery
- •Study lesion involving a true bifurcation lesion with a SB >2.5mm
- •Severe tortuosity
- •Distal embolus
- •Isolated coronary artery spasm
- •Suspected spontaneous coronary artery dissection
- •Chronic total occlusions with treatment indication and no antegrade intra plaque wire pass
研究组 & 干预措施
OCT Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
干预措施: OCT Guided PCI (Procedure)
Angiographic Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
干预措施: Angiographic Guided PCI (Procedure)
结局指标
主要结局
Combined endpoint of major adverse cardiac events (MACE)
时间窗: 12 months
Comprising all-cause death, spontaneous myocardial infarction and stroke
次要结局
- Combined endpoint of major adverse cardiac events (MACE)(30 days, 36 months and 60 months)
- Patient-oriented composite (PoCE) MACE endpoint(30 days, 12 months, 36 months and 60 months)
- All-cause mortality(30 days, 12 months, 36 months, 60 months and 10 years)
- Cardiac death(30 days, 12 months, 36 months and 60 months)
- Spontaneous myocardial infarction(30 days, 12 months, 36 months and 60 months)
- Any ischemia-driven revascularization(30 days, 12 months, 36 months and 60 months)
- Any unplanned revascularization(30 days, 12 months, 36 months and 60 months)
- Ischemia-driven target lesion revascularization(30 days, 12 months, 36 months and 60 months)
- Ischemia-driven target vessel revascularization(30 days, 12 months, 36 months and 60 months)
- Target lesion revascularization(30 days, 12 months, 36 months and 60 months)
- Target vessel revascularization(30 days, 12 months, 36 months and 60 months)
- Stroke(30 days, 12 months, 36 months and 60 months)
- Rose dyspnea Scale(30 days, 12 months, 36 months and 60 months)
- CCS-angina class(30 days, 12 months, 36 months and 60 months)
- Peri-procedure related MI(During or within 48 hours after the procedure (index or staged within the same admission))
- Stent thrombosis(30 days, 12 months, 36 months and 60 months)
- Contrast induced nephropathy(48h)
研究者
Evald Hoej Christiansen
Prof., MD, PhD
Aarhus University Hospital Skejby