Intravascular Ultrasound-derived Assessment of Hemodynamically Negative Lesions in NSTEACS Patients
- Conditions
- Non-ST-segment Acute Coronary Syndrome
- Interventions
- Procedure: FFR-guided PCIDiagnostic Test: Intravascular ultrasound
- Registration Number
- NCT03641898
- Lead Sponsor
- Tianjin Chest Hospital
- Brief Summary
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs.
- Detailed Description
IMPACT-NSTEACS is a prospective, single-centre and dynamic observational study. The study population consists of NSTEACS patients who undergo FFR in lesions with intermediate to severe angiographic stenosis. Then, FFR-guided PCI is performed, followed by morphological assessment based on IVUS in all FFR-negative lesions (FNLs). After discharge all patients receive optimal medication treatment and are followed up clinically. On the basis of follow-up angiography, MACEs are further adjudicated as occurring at FNLs or not.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Moderate to high risk NSTEACS requiring invasive strategy based on current guidelines and local clinical practice.
- Patient agrees and is able to follow all protocol procedures.
Clinical
- STEMI or SCAD.
- Hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction ≤30%).
- Contraindication for FFR, PCI, IVUS and OMT (e.g. severe allergy to antiplatelet drug or contrast, significant bleed within the past 6 months, bleeding diathesis and serum creatinine ≥2.5 mg/dl).
- PCI within 6 months or any prior CABG.
- Anticipated life expectancy <3 year.
- Pregnancy
- Unwilling or unable to provide informed consent
Imaging Inclusion Criteria
- Patients must have at least > 1 de novo lesion in a native coronary segment with a visually estimated diameter stenosis of between 40 and 90 %.
- Successful FFR-guided PCI performed in all major epicardial coronary arteries (including their branches): PCI for all lesions a) with 40%-90% diameter stenosis and FFR<0.8 and b) with ≥90% diameter stenosis.
- The FFR-negative lesions must be available for assessment of IVUS.
Imaging Exclusion Criteria:
- Target lesion reference diameter <2.0 mm.
- Anatomic conditions precluding FFR and IVUS (e.g. marked calcification or tortuosity, chronic total occlusion or thrombus).
- After successful FFR-guided PCI, no FNL is left.
- Any remaining lesion with diameter stenosis ≥90% or FFR<0.8 after PCI.
- Left main coronary artery lesion.
- CABG planned by the investigators according to extent and severity of coronary artery disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Morphometric assessment of FNLs FFR-guided PCI After FFR-guided PCI, the morphometric characteristics of FNLs (FFR\>0.8) are assessment by intravascular ultrasound. Morphometric assessment of FNLs Intravascular ultrasound After FFR-guided PCI, the morphometric characteristics of FNLs (FFR\>0.8) are assessment by intravascular ultrasound.
- Primary Outcome Measures
Name Time Method The incidence and predictors of MACEs related to FNLs 3 years Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
- Secondary Outcome Measures
Name Time Method The incidence of MACEs related to PCI-treated lesions 3 years Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Trial Locations
- Locations (1)
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China