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Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation to Assess Peripheral Artery Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation to Assess Peripheral Artery Disease

Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation During a Provocative Leg Elevation Maneuver to Assess Peripheral Artery Disease: A Multicenter Study.

NCT07397494•Kent Imaging Inc

View on ClinicalTrials.gov

Summary

This is a proof-of-concept study with exploratory objective to assess whether superficial tissue oxygenation patterns measured by Snapshot NIRS, in conjunction with the Provocative Elevation Maneuver of the Lower Extremity (PEMLE) and/or the Plantar Palmar Index (PPI), are associated with the severity of peripheral arterial disease (PAD) as determined by standard of care assessments and can be used to assess tissue oxygenation after revascularization, where applicable.

Eligibility

Age

21 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects between the ages of 21 and 99 years inclusive at the time of screening referred to the investigative site for further evaluation of known/suspected PAD.
•Subject has at least 1 intact forefoot.
•Can achieve leg positions as specified in the protocol to complete the study.
•Willing and able to provide written consent and adhere to protocol requirements

Exclusion Criteria

•The subject is unwilling or unable to comply with the protocol (including but not limited to ability to tolerate leg lift) or scheduled appointments.
•The subject has had higher than trans metatarsal amputation on both limbs.
•Subjects who are pregnant, nursing or plan to become pregnant.
•For any reason as deemed appropriate by the Principal Investigator to be unsuitable for the study.

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

February 9, 2026

Enrollment

200

ESTIMATED participants

Conditions

Peripheral Arterial Disease

Interventions

Observational study only.

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation to Assess Peripheral Artery Disease

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

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