Status:
UNKNOWN
Tissue Monitoring During Endovascular Intervention
Lead Sponsor:
Pedra Technology, PTE LTD
Conditions:
Peripheral Arterial Disease
Peripheral Artery Disease
Eligibility:
All Genders
40-90 years
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 measurem...
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 measurem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04744870
Start Date
March 1 2021
End Date
March 1 2022
Last Update
February 9 2021
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