Tissue Monitoring During Endovascular Intervention

NCT04744870 | Unknown

• 1 other identifier: CIP-002
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease; Peripheral Artery Disease; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Relationship between interventional events of procedure and perfusion changes detected by Xauron System

  Measured at the SOC index procedure

• Relationship of perfusion data from different anatomical locations during procedure

  Measured at the SOC index procedure

• User feedback from the team in the angiographic suite

  Measured at the SOC index procedure

• Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Walking Score.

  Measured through 3-month follow-up

• Angiographic images to evaluate and understand perfusion monitoring

  Measured at the SOC index procedure

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pedra Technology, PTE LTD: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Jeremy Moyer

CONTACT

610-509-6727; jmoyer@abioclinical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: March 1, 2022
• Last Updated: February 9, 2021

Record last verified: 2021-02