N/A
N=12
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03480685 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Visualization of Vessel Morphology: Layered Structure — 1.61; 1.49 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IVUS and OCT Imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Avinger, Inc.
- Primary completion
- Aug 2018
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 | — |
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).
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.