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Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound — SPECTRUM  

Coronary Artery Disease Clinical Trial

Official title:
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05007535
Study type Observational
Source Erasmus Medical Center
Contact
Status Active, not recruiting
Phase
Start date November 10, 2020
Completion date February 2, 2023
View Details
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