Clinical trial NCT04744870: Tissue Monitoring During Endovascular Intervention
Official title: Tissue Monitoring During Endovascular Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Peripheral Artery Disease
Arterial Occlusive Diseases
Lead sponsor: Pedra Technology, PTE LTD
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a prospective, multi-center, observational, feasibility study to collect tissue perfusion data throughout the duration of a standard of care (SOC) endovascular intervention, alongside live video capture of the angiography utilized during the case. The study will enroll up to 80 subjects between the ages of 40 and 90 who are undergoing endovascular intervention for the management of their PAD. The protocol is designed for sites to enroll approximately half of the subjects with primary "below the knee disease".

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.

Eligibility criteria: Inclusion Criteria:

* The subject is undergoing endovascular intervention for the management of their PAD.
* The subject is between 40 and 90 years of age.
* 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.
* In the opinion of the Investigator, the subject is willing and able to comply with the protocol and complete all protocol assessments.
* 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:

* 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.
* Presence of a condition that the Investigator considers will compromise the subject's ability to participate in the study.
* Subjects on renal replacement therapy
* Signs of active infection causing localized inflammation on the plantar or dorsal surfaces of the foot.
* Diabetic subjects with a Charcot neuropathic osteoarthropathy
* 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.

Primary outcomes:
measure: 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.
timeFrame: Measured at the SOC index procedure
Secondary outcomes:
measure: Relationship between interventional events of procedure and perfusion changes detected by Xauron System
timeFrame: Measured at the SOC index procedure
measure: Relationship of perfusion data from different anatomical locations during procedure
timeFrame: Measured at the SOC index procedure
measure: User feedback from the team in the angiographic suite
timeFrame: Measured at the SOC index procedure
measure: Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Walking Score.
timeFrame: Measured through 3-month follow-up
measure: Angiographic images to evaluate and understand perfusion monitoring
timeFrame: Measured at the SOC index procedure
measure: Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Pain Score.
timeFrame: Measured through 3-month follow-up
measure: Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the SF-36 Score
timeFrame: Measured through 3-month follow-up
Other outcomes:
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