Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI).
Objectives:
- To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
- To assess IVUS-guided optimization in STEMI patients.
- To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
- To assess and quantify thrombus in STEMI patients with HD-IVUS.
- To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.
详细描述
The SPECTRUM study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (HD)-IVUS as guidance for primary PCI in 200 patients with STEMI. This study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 MHz HD-IVUS catheter.
All study patients will have a protocolized pre-intervention IVUS pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention IVUS pullback. Subsequently, if IVUS-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization IVUS pullback.
The primary study outcomes are target vessel failure at 12 months and incidence of IVUS-guided optimization. More information on outcome measures is provided in the section below.
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
- •Native coronary artery culprit lesion, angiographically
- •Culprit vessel reference diameter ≥ 2.25 mm, angiographically
排除标准
- •Cardiogenic shock
- •Presentation > 12 hours after symptom onset
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 12 Months
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
IVUS-guided optimization
时间窗: Procedural
Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI
次要结局
- Major Intraprocedural Complications(Procedural)
- Individual Components of TVF and MACE(12 months)
- TVF(30 Days)
- Major Adverse Cardiovascular Events (MACE)(12 Months)
- Angiographic Endpoints(Procedural)
- IVUS endpoints (categorical)(Procedural)
- IVUS endpoints (continuous)(Procedural)
研究者
Joost Daemen
Principal Investigator
Erasmus Medical Center