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NCT03791320: FASTII
Fast Assessment of STenosis Severity- FASTII Study
trial testing Vessel Fractional Flow Reserve in Coronary Artery Disease in 330 participants. Completed in 1 November 2019.
1 September 2019
Quick facts
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 330 |
| Start date | 15 October 2018 |
| Primary completion | 1 September 2019 |
| Estimated completion | 1 November 2019 |
| Sites | 6 locations across France, Italy, Japan, Netherlands, Germany, United States |
Drugs / interventions tested
- Vessel Fractional Flow Reserve
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03791320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03791320 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erasmus Medical Center
- Last refreshed: 24 December 2020
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing