Intravascular Ultrasound-derived Assessment of Hemodynamically Negative Lesions in NSTEACS Patients (IMPACT-NSTEACS)

Tianjin Chest Hospital

Status: Enrolling

Conditions: Non-ST-segment Acute Coronary Syndrome

Treatments: Procedure: FFR-guided PCI; Diagnostic Test: Intravascular ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT03641898

16KG132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Clinical Inclusion Criteria:

1. Moderate to high risk NSTEACS requiring invasive strategy based on current guidelines and local clinical practice.
2. Patient agrees and is able to follow all protocol procedures.

Clinical Exclusion Criteria:

1. STEMI or SCAD.
2. Hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction ≤30%).
3. 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).
4. PCI within 6 months or any prior CABG.
5. Anticipated life expectancy <3 year.
6. Pregnancy
7. Unwilling or unable to provide informed consent

Imaging Inclusion Criteria

1. 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 %.
2. 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.
3. The FFR-negative lesions must be available for assessment of IVUS.

Imaging Exclusion Criteria:

1. Target lesion reference diameter <2.0 mm.
2. Anatomic conditions precluding FFR and IVUS (e.g. marked calcification or tortuosity, chronic total occlusion or thrombus).
3. After successful FFR-guided PCI, no FNL is left.
4. Any remaining lesion with diameter stenosis ≥90% or FFR<0.8 after PCI.
5. Left main coronary artery lesion.
6. CABG planned by the investigators according to extent and severity of coronary artery disease.

Trial design

350 participants in 1 patient group

Morphometric assessment of FNLs

Description:

After FFR-guided PCI, the morphometric characteristics of FNLs (FFR\>0.8) are assessment by intravascular ultrasound.

Treatment:

Procedure: FFR-guided PCI

Diagnostic Test: Intravascular ultrasound