Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Kent Imaging

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: SnapshotNIR imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06237621

20230638HU

Details and patient eligibility

About

The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.

Full description

This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.

Enrollment: 150 estimated patients

Sex: All

Ages: 35 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 35-99 years of age
• Subject has at least 1 intact forefoot
• Can achieve leg positions to complete the study

Exclusion criteria

• The subject is unwilling or unable to comply with the protocol or scheduled appointments.
• The subject has had transmetatarsal amputation or higher on both limbs.
• Vascular intervention within the past year
• Subjects who have had a previous distal bypass procedure
• Pregnant or plans to become pregnant
• Deemed by the PI to be unsuitable for the study

Trial design

150 participants in 1 patient group

People at risk of PAD

Treatment:

Device: SnapshotNIR imaging