MedTrace Logo

FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

NCT02943954 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1170

Last updated 2021-11-19

No results posted yet for this study

Summary

Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).

The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.

The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.

Conditions

  • Acute ST Segment Elevation Myocardial Infarction
  • Acute Myocardial Infarction
  • Multi Vessel Coronary Artery Disease

Interventions

PROCEDURE

Angiography guided PCI

DEVICE

Fractional Flow Reserve (FFR)

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Etienne PUYMIRAT, MD · AP - HP, Hôpital Europeen Georges-Pompidou, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-10-24
Completion
2022-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02943954 on ClinicalTrials.gov