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NCT03791320: FASTII

Fast Assessment of STenosis Severity- FASTII Study

Completed Last updated 24 December 2020
What this trial tests

trial testing Vessel Fractional Flow Reserve in Coronary Artery Disease in 330 participants. Completed in 1 November 2019.

Timeline
15 October 2018
Primary endpoint
1 September 2019
1 November 2019

Quick facts

Lead sponsorErasmus Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment330
Start date15 October 2018
Primary completion1 September 2019
Estimated completion1 November 2019
Sites6 locations across France, Italy, Japan, Netherlands, Germany, United States

Drugs / interventions tested

Conditions studied

Sponsor

Erasmus Medical Center

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.
    Masdjedi K, Tanaka N, Van Belle E, Porouchani S, et al · · 2022 · cited 59× · PMID 34647890 · DOI 10.4244/eij-d-21-00471
  2. Validation of novel 3-dimensional quantitative coronary angiography based software to calculate fractional flow reserve post stenting.
    Masdjedi K, van Zandvoort LJ, Balbi MM, Nuis RJ, et al · · 2021 · cited 20× · PMID 33022098 · DOI 10.1002/ccd.29311
  3. Correlation between 3D-QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses.
    Tomaniak M, Masdjedi K, van Zandvoort LJ, Neleman T, et al · · 2021 · cited 11× · PMID 32725862 · DOI 10.1002/ccd.29151
  4. Coronary Physiology Derived from Invasive Angiography: Will it be a Game Changer?
    Gabara L, Hinton J, Gunn J, Morris PD, et al · · 2020 · cited 9× · PMID 32577131 · DOI 10.15420/icr.2019.25
  5. Three-dimensional QCA-based vessel fractional flow reserve (vFFR) in Heart Team decision-making: a multicentre, retrospective, cohort study.
    Tomaniak M, Masdjedi K, Neleman T, Kucuk IT, et al · · 2022 · cited 2× · PMID 35379622 · DOI 10.1136/bmjopen-2021-054202

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other Erasmus Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03791320.

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