SPECTRUM: Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
Study Details
Study Description
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:
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To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
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To assess IVUS-guided optimization in STEMI patients.
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To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
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To assess and quantify thrombus in STEMI patients with HD-IVUS.
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To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HD-IVUS-guided primary PCI Prospective, single arm, observational |
Outcome Measures
Primary Outcome Measures
- Target Vessel Failure (TVF) [12 Months]
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
- IVUS-guided optimization [Procedural]
Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI
Secondary Outcome Measures
- TVF [30 Days]
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
- Major Adverse Cardiovascular Events (MACE) [30 Days]
A composite of all-cause mortality, any myocardial infarction and repeat revascularization
- Major Adverse Cardiovascular Events (MACE) [12 Months]
A composite of all-cause mortality, any myocardial infarction and repeat revascularization
- Individual Components of TVF and MACE [30 Days]
Individual components of the composite endpoints
- Individual Components of TVF and MACE [12 months]
Individual components of the composite endpoints
- Major Intraprocedural Complications [Procedural]
Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (> 2 mm)
- Angiographic Endpoints [Procedural]
Including final TIMI flow and final myocardial blush grade
- IVUS endpoints (continuous) [Procedural]
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.
- IVUS endpoints (categorical) [Procedural]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Native coronary artery culprit lesion, angiographically
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Culprit vessel reference diameter ≥ 2.25 mm, angiographically
Exclusion Criteria:
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Cardiogenic shock
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Presentation > 12 hours after symptom onset
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus University Medical Center | Rotterdam | Netherlands | 3015GD |
Sponsors and Collaborators
- Erasmus Medical Center
- Acist Medical Systems
- MicroPort CRM
Investigators
- Principal Investigator: Joost Daemen, MD PhD, Erasmus MC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPECTRUM