Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Myocardial Infarction
- 发起方
- Centre Hospitalier Universitaire de Besancon
- 入组人数
- 188
- 试验地点
- 12
- 主要终点
- Functional outcome of the procedure (absolute value)
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.
详细描述
Angiographic evaluation of lesions of the left main stem presents particular challenges and high procedural complexity. The clinical sequelae of a suboptimal result in this context may be severe, and thus, it is recommended that patients with left-main lesions be considered for imaging-guided interventions by means of optimal coherence tomography (OCT) in non-ostial left main lesions. The investigators have previously demonstrated in a randomized trial of patients undergoing PCI for a lesion responsible for non ST elevation acute coronary syndromes that OCT provides useful clinical information beyond that obtained by angiography alone, and OCT-guidance for angioplasty in these patients yielded a significantly higher proportion of patients with an optimal functional result after stenting. In this context, the aim of the present study is to evaluate whether OCT-guided left-main angioplasty is superior to left main angioplasty guided by fluoroscopy alone, as assessed by fractional flow reserve (FFR) measured after stent implantation. Eligible patients must be aged 18 years and over, admitted for acute coronary syndrome (ACS) or stable coronary artery disease (CAD); AND present an angiographically significant non-ostial lesion of the left main stem requiring angioplasty with drug eluting stent implantation.
研究者
入排标准
入选标准
- •Patients aged 18 years or over presenting with:
- •NSTEMI or unstable angina or stable angina or documented silent ischemia AND
- •De novo angiographic lesion (% diameter stenosis \>=50%) or functionally significant (FFR\<=0.80) lesion of the left main stem (median or distal) with or without lesions of the ostia of the LAD and/or circumflex arteries (= Medina classification 1-0-0, 1-0-1, 1-1-0, 1-1-1) or ostial lesion of the LAD and/or circumflex artery requiring angioplasty with stent implantation that will cover the distal left main stem (=Medina classification 0-0-1, 0-1-0 ou 0-1-1) AND
- •SYNTAX score ≤ 22 (or \>22 and ≤32 and validated by the Heart Team)
- •Lesion with reference angiographic diameter \<=5.5mm
- •Signature of written informed consent form.
排除标准
- •Patients with:
- •ST segment elevation myocardial infarction
- •Ostial lesion of the left main stem
- •Technically impossible to perform OCT
- •Creatinine clearance ≤ 30 ml/min/1.73m²
- •Left ventricular ejection fraction \<30%
- •Hypotension or cardiogenic shock
- •Unstable ventricular arrhythmia
- •Contraindication to dual antiplatelet therapy for at least 6 (or 12) months (duration depending on the initial clinical presentation). Shorter dual antiplatelet therapy is possible in patients with long-term anticoagulation.
- •Hypersensitivity or contraindication to any of the antithrombotic therapies used during or after the procedure
结局指标
主要结局
Functional outcome of the procedure (absolute value)
时间窗: At the end of the procedure, once the operator judges the result to be satisfactory.
Functional outcome as assessed by the Fractional flow reserve (FFR) at the end of the procedure (average of at least 3 consecutive measures)
次要结局
- Functional outcome of the procedure (dichotomized)(At the end of the procedure, once the operator judges the result to be satisfactory.)
- Relative change in final FFR value(At the end of the angioplasty procedure)
- Percentage of patients in whom OCT after stent implantation reveals a suboptimal result(Immediately after stent implantation)
- Percentage of patients in whom a change in procedural strategy is decided based on OCT data(Immediately after stent implantation)
- Safety of OCT in angioplasty of the left main stem(At the end of the angioplasty procedure)
- OCT data that predict final FFR value >=0.90(At the end of the angioplasty procedure)