Peripheral Arterial Disease Clinical Trial
— mini-TIMEOfficial title:
Preliminary Tissue Monitoring During Endovascular Intervention Study
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pedra Technology, PTE LTD |
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 he angiography suite clinical workflow. | Measured at the SOC index procedure | |
Secondary | Relationship between interventional events of procedure and perfusion changed detected but the Xauron System | Measure the time from end of an intervention to the zenith or nadir of the subsequent perfusion change | Measured at the standard of care (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 | 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 |
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