Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.

Summary

The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.

Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.

Approximately 885 patients will be entered in the study.

Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.

Conditions

• Myocardial Infarction
• Multivessel Coronary Artery Disease

Interventions

PROCEDURE

FFR-guided revascularisation strategy

FFR-guided revascularisation strategy

PROCEDURE

randomised to guidelines group

Staged revascularisation by proven ischemia or persistence of symptoms of angina

Sponsors & Collaborators

• Abbott Medical Devices

  collaborator INDUSTRY

• Maasstad Hospital

  lead OTHER

Principal Investigators

• Peter Smits, MD. PHD · Maastadhospital / MCR

• Elmir Omerovic, MD PhD · Sahlgrenska Hospital Götheborg

• Gert Richardt, MD PhD · Herzzentrum Segeberger Kliniken

• Franz-Josef Neumann, MD PhD · Herz-Zentrum Bad Krozingen

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

2011-07-31

Primary Completion

2016-10-31

Completion

2018-10-31

Countries

• Czechia
• Germany
• Hungary
• Netherlands
• Norway
• Poland
• Singapore
• Sweden

Study Locations