Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

Coronary Artery Disease Clinical Trial

— SPECTRUM  

Official title:

Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05007535
• Other study ID #: SPECTRUM
• Status: Active, not recruiting
• Start date: November 10, 2020
• Est. completion date: February 2, 2023

Study information

• Verified date: January 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Acist Medical Systems, MicroPort CRM

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure (TVF)	A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization	12 Months
Primary	IVUS-guided optimization	Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI	Procedural
Secondary	TVF	A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization	30 Days
Secondary	Major Adverse Cardiovascular Events (MACE)	A composite of all-cause mortality, any myocardial infarction and repeat revascularization	30 Days
Secondary	Major Adverse Cardiovascular Events (MACE)	A composite of all-cause mortality, any myocardial infarction and repeat revascularization	12 Months
Secondary	Individual Components of TVF and MACE	Individual components of the composite endpoints	30 Days
Secondary	Individual Components of TVF and MACE	Individual components of the composite endpoints	12 months
Secondary	Major Intraprocedural Complications	Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (> 2 mm)	Procedural
Secondary	Angiographic Endpoints	Including final TIMI flow and final myocardial blush grade	Procedural
Secondary	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
Secondary	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