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

NCT ID: NCT03641898

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2025-10-31

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.

Conditions

Non-ST-segment Acute Coronary Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Morphometric assessment of FNLs

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

FFR-guided PCI

Intervention Type: PROCEDURE

After the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or \>90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR \>0.80 are defined as FNLs and should result in deferral of PCI.

Intravascular ultrasound

Intervention Type: DIAGNOSTIC_TEST

After the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area.

Interventions

FFR-guided PCI

After the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or \>90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR \>0.80 are defined as FNLs and should result in deferral of PCI.

Intervention Type: PROCEDURE

Intravascular ultrasound

After the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Functionally complete revascularization

Eligibility Criteria

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.

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.

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ying Zhang

Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Zhang, MD

Role: STUDY_CHAIR

Tianjin Chest Hospital

Locations

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Zhou, MD

Role: CONTACT

zhoujiawenzhang@126.com

86-15522485560

Facility Contacts

Jia Zhou, MD

Role: primary

zhoujiawenzhang@126.com

86-15522485560

Other Identifiers

16KG132

Identifier Type: -

Identifier Source: org_study_id