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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05007535
Other study ID # SPECTRUM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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