Clinical trial NCT05007535: Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
Official title: Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST Elevation Myocardial Infarction
Acute Myocardial Infarction
Coronary Artery Disease
Percutaneous Coronary Intervention
Intravascular Ultrasound
Thrombus
Keywords: Invasive Coronary Imaging
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Acist Medical Systems
name: MicroPort CRM
First posted: 2021-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 Months
measure: IVUS-guided optimization
timeFrame: Procedural
Secondary outcomes:
measure: TVF
timeFrame: 30 Days
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 30 Days
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 12 Months
measure: Individual Components of TVF and MACE
timeFrame: 30 Days
measure: Individual Components of TVF and MACE
timeFrame: 12 months
measure: Major Intraprocedural Complications
timeFrame: Procedural
measure: Angiographic Endpoints
timeFrame: Procedural
measure: IVUS endpoints (continuous)
timeFrame: Procedural
measure: IVUS endpoints (categorical)
timeFrame: Procedural
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Joost Daemen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groenland FTW, Mahmoud KD, Neleman T, Ziedses des Plantes AC, Scoccia A, Ligthart J, Witberg KT, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Kardys I, Cummins P, Van Mieghem NM, Daemen J. Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Open Heart. 2022 Apr;9(1):e001955. doi: 10.1136/openhrt-2021-001955.