Trials / Completed
CompletedNCT03480685
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Avinger, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
Patients requiring diagnostic imaging of peripheral vessels to determine vessel condition and planning treatment strategy will have vessel segments imaged by both OCT and IVUS imaging catheters. The images will be collected into a library and independent readers will rank each image on the quality of vessel morphology and disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IVUS and OCT Imaging | Use of an imaging catheter |
Timeline
- Start date
- 2018-05-24
- Primary completion
- 2018-08-01
- Completion
- 2018-10-01
- First posted
- 2018-03-29
- Last updated
- 2021-06-14
- Results posted
- 2021-06-14
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03480685. Inclusion in this directory is not an endorsement.