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FAME II-10-year Follow-Up

NCT06159231 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 888

Last updated 2025-01-07

No results posted yet for this study

Summary

The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design.

The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence.

FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published.

The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).

Patients will have to sign a specific informed consent for the present 10-year follow-up.

This study will be conducted for about approximately 6 months.

Conditions

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • CoreAalst BV

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-05-15
Completion
2024-05-15

Countries

  • United States
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Serbia
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT06159231 on ClinicalTrials.gov