FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease

Last updated: August 11, 2025
Sponsor: Zuyderland Medisch Centrum
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Disease

Atherosclerosis

Treatment

Ischemia driven revascularization

Usual care group

Clinical Study ID

NCT03562572
17-T-142
28708
  • Ages 18-85
  • All Genders

Study Summary

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged between 18-85 years presenting with non-STEMI according to currentguidelines, who will be treated with PCI of the culprit and have at least onestenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiographyand judged feasible for treatment with PCI by the operator.

  • Non-IRA stenosis amenable for PCI treatment (operator's decision)

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Left main disease (stenosis > 50%)

  • Chronic total occlusion of a non-IRA

  • Indication for or previous coronary artery bypass grafting

  • Uncertain culprit lesion

  • Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRAtreatment (TIMI flow 0-1) and inability to implant a stent

  • Known severe cardiac valve dysfunction that will require surgery or TAVI in thefollow-up period.

  • Killip class III or IV during the completion of culprit lesion treatment.

  • Life expectancy of < 1 year.

  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.

  • Gastrointestinal or genitourinary bleeding within the prior 3 months.

  • Planned elective surgical procedure necessitating interruption of thienopyridinesduring the first 6 months post enrolment.

  • Patients who are actively participating in another drug or device investigationalstudy, which have not completed the primary endpoint follow-up period.

  • Pregnancy

Study Design

Total Participants: 476
Treatment Group(s): 2
Primary Treatment: Ischemia driven revascularization
Phase:
Study Start date:
June 07, 2018
Estimated Completion Date:
July 31, 2027

Study Description

Background:

Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD.

Objective:

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Design:

Prospective, multicentre, 1:1 randomized, investigator initiated study.

Hypothesis:

FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.

Connect with a study center

  • Brno University Hospital

    Brno,
    Czechia

    Site Not Available

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest,
    Hungary

    Site Not Available

  • Bacs-Kiskun Teaching Hospital

    Kecskemét,
    Hungary

    Site Not Available

  • Szeged University

    Szeged,
    Hungary

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    Den Bosch,
    Netherlands

    Site Not Available

  • Zuyderland MC

    Heerlen,
    Netherlands

    Site Not Available

  • Maastricht University Medical Centre

    Maastricht,
    Netherlands

    Site Not Available

  • Radboud University Medical Centre

    Nijmegen,
    Netherlands

    Site Not Available

  • Viecuri Medisch Centrum

    Venlo,
    Netherlands

    Site Not Available

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