Tissue Monitoring During Endovascular Intervention

Peripheral Arterial Disease Clinical Trial

— TIME  

Official title:

Tissue Monitoring During Endovascular Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04744870
• Other study ID #: CIP-002
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2021
• Source: Pedra Technology, PTE LTD
• Contact: Jeremy Moyer
• Phone: 610-509-6727
• Email: jmoyer[@]abioclinical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pedra Technology, PTE LTD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	To confirm that the Xauron system can be integrated into the angiography suite clinical workflow.	Measured at the SOC index procedure
Secondary	Relationship between interventional events of procedure and perfusion changes detected by Xauron System	Measure the time from end of an intervention to the zenith or nadir of the subsequent perfusion change	Measured at the SOC index procedure
Secondary	Relationship of perfusion data from different anatomical locations during procedure	Determine the ratio of perfusion in the arm relative to the foot after an intervention	Measured at the SOC index procedure
Secondary	User feedback from the team in the angiographic suite	To obtain user feedback from the team in the angiography suite, to improve the user interface between the device and the operators.	Measured at the SOC index procedure
Secondary	Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Walking Score.	Evaluate the relationship between changes in perfusion during the intervention and the clinical outcomes of the patients in terms of changes in the Walking Score.	Measured through 3-month follow-up
Secondary	Angiographic images to evaluate and understand perfusion monitoring	Collate data and angiographic images/video that may help endovascular teams understand and utilize perfusion monitoring in the angiography suite.	Measured at the SOC index procedure
Secondary	Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Pain Score.	Evaluate the relationship between changes in perfusion during the intervention and the clinical outcomes of the patients in terms of changes in the Pain Score.	Measured through 3-month follow-up
Secondary	Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the SF-36 Score	Evaluate the relationship between changes in perfusion during the intervention and the clinical outcomes of the patients in terms of changes in the SF-36 score.	Measured through 3-month follow-up