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

Last updated: February 3, 2023
Sponsor: Zuyderland Medisch Centrum
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Vascular Diseases

Cardiac Surgery

Treatment

N/A

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 one stenosisof >50% in a non-IRA on QCA or visual estimation of baseline angiography and judgedfeasible 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
Study Start date:
June 07, 2018
Estimated Completion Date:
January 01, 2028

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

    Active - Recruiting

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest,
    Hungary

    Active - Recruiting

  • Bacs-Kiskun Teaching Hospital

    Kecskemét,
    Hungary

    Active - Recruiting

  • Szeged University

    Szeged,
    Hungary

    Active - Recruiting

  • Jeroen Bosch Ziekenhuis

    Den Bosch,
    Netherlands

    Active - Recruiting

  • Zuyderland MC

    Heerlen,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Centre

    Maastricht,
    Netherlands

    Active - Recruiting

  • Viecuri Medisch Centrum

    Venlo,
    Netherlands

    Active - Recruiting

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