NCT03641898

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

5 years

First QC Date

August 18, 2018

Last Update Submit

July 9, 2019

Conditions

Non-ST-segment Acute Coronary Syndrome

Keywords

Fractional flow reserveIntravascular ultrasoundMajor adverse cardiovascular eventsNon-ST-segment acute coronary syndromePercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • The incidence and predictors of MACEs related to FNLs

    Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization

    3 years

Secondary Outcomes (1)

  • The incidence of MACEs related to PCI-treated lesions

    3 years

Other Outcomes (2)

  • The incidence and predictors of MACEs related to FNLs

    5 years

  • The incidence of MACEs related to PCI-treated lesions

    5 years

Study Arms (1)

Morphometric assessment of FNLs

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

Procedure: FFR-guided PCIDiagnostic Test: Intravascular ultrasound

Interventions

FFR-guided PCIPROCEDURE

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.

Also known as: Functionally complete revascularization
Morphometric assessment of FNLs
Intravascular ultrasoundDIAGNOSTIC_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.

Morphometric assessment of FNLs

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For study enrollment, we screen patients with NSTEACS combination of unstable angina and non-ST-segment elevation myocardial infarction according to current guidelines. Once all clinical inclusion criteria and no clinical exclusion criteria are met, patients must sign the informed consent and undergo invasive coronary angiography (ICA). During ICA patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients will be enrolled into the study once the IVUS measurement is delivered after successful FFR-guided PCI.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Interventional

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ying Zhang, MD

    Tianjin Chest Hospital

    STUDY CHAIR

Central Study Contacts

Jia Zhou, MD

CONTACT

86-15522485560zhoujiawenzhang@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

August 18, 2018

First Posted

August 22, 2018

Study Start

October 20, 2018

Primary Completion

October 1, 2023

Study Completion

October 1, 2025

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

CN(1)