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NCT01233518 · ClinicalTrials.gov registry record · NA
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
A NA study, sponsored by HeartFlow.
- Completed
- Registry status
- NA
- Development phase
- 285
- Enrollment target
NCT01233518: Completed NA study, sponsored by HeartFlow.
NCT01233518 is a NA study that has completed, run by HeartFlow. The registered enrollment target is 285 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01233518, a NA study, has completed, sponsored by HeartFlow.
- COMPLETED
- Registry status
- NA
- Development phase
- 285 participants
- Enrollment target
Study Summary
This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
Primary Outcome
Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and
Interventions
- DEVICE FFR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-11 |
| Phase | NA |
What the finished NCT01233518 record still lists
NCT01233518 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which FFR is the first listed.
NCT01233518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01233518 about?
NCT01233518 is a clinical study titled "Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography". This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic sig...
What is the current status of trial NCT01233518?
This trial is currently completed. It is a NA study. The enrollment target is 285 participants. The study started on 2010-10. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01233518?
The interventions under investigation include: FFR (DEVICE).
Who is sponsoring clinical trial NCT01233518?
This trial is sponsored by HeartFlow, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01233518's enrollment target sits among peer trials
285 377th of 2000 higher than 1,624 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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