Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

Conditions
-----------------
ST Elevation Myocardial Infarction, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Intravascular Ultrasound, Thrombus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Native coronary artery culprit lesion, angiographically Culprit vessel reference diameter ≥ 2.25 mm, angiographically Exclusion Criteria: Cardiogenic shock Presentation > 12 hours after symptom onset

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HD-IVUS-guided primary PCI<br>Prospective, single arm, observational | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) | A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization | 12 Months | 
| IVUS-guided optimization | Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI | Procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TVF | A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization | 30 Days | 
| Major Adverse Cardiovascular Events (MACE) | A composite of all-cause mortality, any myocardial infarction and repeat revascularization | 30 Days | 
| Major Adverse Cardiovascular Events (MACE) | A composite of all-cause mortality, any myocardial infarction and repeat revascularization | 12 Months | 
| Individual Components of TVF and MACE | Individual components of the composite endpoints | 30 Days | 
| Individual Components of TVF and MACE | Individual components of the composite endpoints | 12 months | 
| Major Intraprocedural Complications | Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (> 2 mm) | Procedural | 
| Angiographic Endpoints | Including final TIMI flow and final myocardial blush grade | Procedural | 
| IVUS endpoints (continuous) | At least the following continuous variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks: Minimal lumen area Thrombus containing frames Thrombus maximum angle Minimal stent area Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software. | Procedural | 
| IVUS endpoints (categorical) | At least the following categorical variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks: Plaque rupture Convex calcium (nodule) Thrombus type Plaque type Thrombus protrusion Underexpansion Edge dissection Hematoma High plaque burden at stent edges Residual focal lesion Malapposition Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software. | Procedural | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Invasive Coronary Imaging