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

Summary

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

Conditions

• Coronary Artery Disease
• NSTEMI - Non-ST Segment Elevation MI
• Fractional Flow Reserve, Myocardial
• Myocardial Revascularization
• Percutaneous Coronary Intervention

Interventions

PROCEDURE

Ischemia driven revascularization

In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention

OTHER

Usual care group

In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• VieCuri Medical Centre

  collaborator OTHER

• Gottsegen György Országos Kardiológiai Intézet

  collaborator UNKNOWN

• Bács-Kiskun County Teaching Hospital

  collaborator OTHER

• Brno University Hospital

  collaborator OTHER

• Szeged University

  collaborator OTHER

• Zuyderland Medisch Centrum

  lead OTHER

Principal Investigators

• Saman Rasoul, Dr. · Zuyderland MC

• Arnoud van 't Hof, Prof. Dr. · Zuyderland MC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-07

Primary Completion

2025-07-21

Completion

2027-07-31

Countries

• Czechia
• Hungary
• Netherlands

Study Locations