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

Erasmus University

Status: Active, not recruiting

Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Intravascular Ultrasound; Acute Myocardial Infarction; Thrombus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05007535

SPECTRUM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

HD-IVUS-guided primary PCI

Description:

Prospective, single arm, observational