Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

Active, not recruiting

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

• Registration Number: NCT05007535
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2020-11-10
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-16
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Major Intraprocedural Complications	Procedural	Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (\> 2 mm)
Individual Components of TVF and MACE	12 months	Individual components of the composite endpoints
TVF	30 Days	A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
Major Adverse Cardiovascular Events (MACE)	12 Months	A composite of all-cause mortality, any myocardial infarction and repeat revascularization
Angiographic Endpoints	Procedural	Including final TIMI flow and final myocardial blush grade
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.
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.

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands