Trials / Unknown
UnknownNCT05007535
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- ST Elevation Myocardial Infarction
- Acute Myocardial Infarction
- Coronary Artery Disease
- Percutaneous Coronary Intervention
- Intravascular Ultrasound
- Thrombus
Timeline
- Start date
- 2020-11-10
- Primary completion
- 2023-02-02
- Completion
- 2023-02-02
- First posted
- 2021-08-16
- Last updated
- 2023-01-18
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05007535. Inclusion in this directory is not an endorsement.