Coronary Artery Disease Clinical Trial
— SPECTRUMOfficial title:
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
Verified date | January 2023 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus University Medical Center | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Acist Medical Systems, MicroPort CRM |
Netherlands,
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. |
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