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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03480685
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Avinger, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: diagnostic imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Images will be identified by number not associated with case, patient, or institution.
Primary Purpose: Diagnostic
Official Title: A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging
Actual Study Start Date : May 24, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: IVUS catheter
A vessel segment will be imaged with an IVUS catheter.
Device: diagnostic imaging
Use of an imaging catheter

Active Comparator: OCT catheter
The same vessel segment will be imaged with an OCT catheter
Device: diagnostic imaging
Use of an imaging catheter

Primary Outcome Measures :
  1. Ranking of visualization of vessel morphology [ Time Frame: During the procedure ]
    Ranking of layered structures, abnormal physiology, bifurcations, and artifacts

Secondary Outcome Measures :
  1. Vessel measurement [ Time Frame: During the procedure ]
    Measure diameter and total luminal area of vessel segments

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03480685

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United States, Illinois
Adventis Midwest Health
Hinsdale, Illinois, United States, 60521
United States, Pennsylvania
Pottstown Hospital
Pottstown, Pennsylvania, United States, 19464
Sponsors and Collaborators
Avinger, Inc.
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Study Director: Thomas Lawson, PhD Avinger, Inc.

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Responsible Party: Avinger, Inc. Identifier: NCT03480685     History of Changes
Other Study ID Numbers: P0986
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases