Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging (SCAN)

Avinger

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: IVUS and OCT Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT03480685

P0986

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

IVUS Imaging vs. OCT Imaging

Other group

Description:

A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).

Treatment:

Device: IVUS and OCT Imaging