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Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

NCT04931771 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2228

Last updated 2023-10-18

No results posted yet for this study

Summary

The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Patients will be consented prior to the procedure and then followed up to 12 (+1) months after randomization. The primary endpoint is analyzed at 12 months after randomization. Approximately 35 sites in 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France).

Conditions

Interventions

DEVICE

vFFR guided revascularization

3D-angio-based vessel FFR (CAAS, Pie Medical Imaging, Maastricht, The Netherlands) uses 3-Dimensional Quantitative Coronary Angiography (3D-QCA) for functional assessment of coronary stenosis. vFFR is calculated using two angiographic views with at least 30 degrees difference in rotation/angulation to generate the 3D reconstruction of the coronary artery.

DEVICE

FFR guided revascularization

Fractional flow reserve (FFR) is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia)

Sponsors & Collaborators

  • Siemens Healthineers AG

    collaborator UNKNOWN

  • Pie Medical Imaging

    collaborator UNKNOWN

  • ECRI bv

    lead INDUSTRY

Principal Investigators

  • Joost Daemen, MD, PhD · Erasmus Medical Center

  • Ernest Spitzer, MD · European Cardiovascular Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

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 NCT04931771 on ClinicalTrials.gov