N/A
Completed N=12
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Source: ClinicalTrials.gov NCT03480685 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Visualization of Vessel Morphology: Layered Structure — 1.61; 1.49 score on a scale
Summary
A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visualization of Vessel Morphology: Layered Structure |
1.61; 1.49 | — |
| PRIMARY Visualization of Vessel Morphology: Non-layered Structure |
2.70; 1.82 | — |
| PRIMARY Visualization of Vessel Morphology: Calcification |
2.45; 2.11 | — |
| PRIMARY Visualization of Vessel Morphology: Stent Structure |
1.79; 1.43 | — |
| PRIMARY Visualization of Vessel Morphology: Artifacts |
1.87; 1.79 | — |
| PRIMARY Freedom From Adverse Events |
0; 0 | — |
| SECONDARY Vessel Measurement: Mean Diameter |
4.7; 4.7; 4.0; 3.8; 4.3; 4.3 | — |
| SECONDARY Vessel Measurement: Total Luminal Area |
18.55; 17.95; 15.36; 14.83; 10.06; 10.26 | — |
Eligibility Criteria
Inclusion Criteria
- adult
- suspected vascular disease that might be a candidate for IVUS
- reference vessel can accommodate imaging catheters
- successful diagnostic imaging and removal of IVUS catheter with no adverse events
Exclusion Criteria
- if female, pregnant or breast-feeding
- unwilling to give informed consent
Data sourced from ClinicalTrials.gov (NCT03480685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.