Trials / Unknown
UnknownNCT04683133
The FAST OCT Study
Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.
Detailed description
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment. Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation. The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI
Conditions
- Tomography, Optical Coherence
- Myocardial Revascularization
- NSTEMI - Non-ST Segment Elevation MI
- Unstable Angina
- Coronary Arteriosclerosis
- 3D-angio-based FFR
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Optical coherence tomography assessment | Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2020-12-24
- Last updated
- 2020-12-24
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04683133. Inclusion in this directory is not an endorsement.