Trials / Completed
CompletedNCT03226262
FFRangio Accuracy vs. Standard FFR
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 382 (actual)
- Sponsor
- CathWorks Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FFRangio | FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques. |
Timeline
- Start date
- 2017-09-27
- Primary completion
- 2018-06-08
- Completion
- 2018-06-08
- First posted
- 2017-07-21
- Last updated
- 2018-06-25
Locations
9 sites across 4 countries: United States, Belgium, Denmark, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03226262. Inclusion in this directory is not an endorsement.