Preliminary Tissue Monitoring During Endovascular Intervention Study

• Conditions: Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Artery Disease

• Registration Number: NCT04956523
• Lead Sponsor: Pedra Technology, PTE LTD

Brief Summary

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

Detailed Description

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

This is a feasibility study to demonstrate the ability of the Xauron system to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease (PAD). The findings of this study are for research purposes and will also be used to help with the future education of physicians about the potential use of the Xauron system. In addition, this early pilot data will be used to help power larger, more definitive studies relating to the intra-procedural use of the Xauron system.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09
• Study Start: 2021-10-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. The subject is undergoing endovascular intervention for the management of their PAD.
2. The subject is between 40 to 90 years of age.
3. Documented lower limb arterial occlusive or stenotic disease (using ankle-brachial index / pulse volume recording, duplex ultrasound or CT angiogram) within the last 8 weeks.
4. In the opinion of the Investigator, the subject is willing and able to comply with the protocol and complete all protocol assessments.
5. The subject has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate Institutional Review Board (IRB)

Exclusion Criteria

1. Subjects on an investigational drug or being treated with an investigational therapeutic device, within 30 days of the study visit, that in the view of the Investigator might interfere with the study outcomes.
2. Presence of a condition that the Investigator considers will compromise the subject's ability to participate in the study.
3. Subjects on renal replacement therapy
4. Signs of active infection causing localized inflammation on the plantar or dorsal surfaces of the foot.
5. Lack of intact skin, or pathological skin conditions, at the proposed sensor pad positions that may impair or prevent the adherence of medical adhesives in general.
6. Diabetic subjects with a Charcot neuropathic osteoarthropathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Integration of Xauron System into clinical workflow - The Investigator will complete a questionnaire assessing that the Xauron system can be integrated within the angiography suite for all subjects observed.	Measured at the SOC index procedure	To confirm that the Xauron system can be integrated into he angiography suite clinical workflow.

Secondary Outcome Measures

Name	Time	Method
Relationship between interventional events of procedure and perfusion changed detected but the Xauron System	Measured at the standard of care (SOC) index procedure	Measure the time from end of an intervention to the zenith or nadir of the subsequent perfusion change
Relationship of perfusion data from different anatomical locations during procedure	Measured at the SOC index procedure	Determine the ratio of perfusion in the arm relative to the foot after an intervention
User feedback from the team in the angiographic suite	Measured at the SOC index procedure	To obtain user feedback from the team in the angiography suite to improve the user interface between the device and the operators.
Angiographic images to evaluate and understand perfusion monitoring	Measured at the SOC index procedure	Collate data and angiographic images/video that may help endovascular teams understand and utilize perfusion monitoring in the angiography suite.