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

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ClinicalTrials.gov Identifier: NCT03480685
Recruitment Status : Enrolling by invitation
First Posted : March 29, 2018
Last Update Posted : June 8, 2018
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

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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



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03480685


Locations
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.
Investigators
Study Director: Thomas Lawson, PhD Avinger, Inc.

Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT03480685     History of Changes
Other Study ID Numbers: P0986
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases