Peripheral Arterial Diseasemini-TIMENCT04956523
Preliminary Tissue Monitoring During Endovascular Intervention Study
An observational study of Peripheral Arterial Disease and Peripheral Artery Disease, run by Pedra Technology, PTE LTD.
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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Artery Disease, Arterial Occlusive Diseases
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 data capture of the angiography utilized during the case. The study will enroll up to 20 subjects between the ages of 40 and 90 who are undergoing endovascular intervention for the management of their PAD. Sites to enroll approximately half of the subjects with primary "below the knee disease".
Who may be able to join
- The subject is undergoing endovascular intervention for the management of their PAD.
- The subject is between 40 to 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.
- 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)
Who cannot join
- 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.
- 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.
- Diabetic subjects with a Charcot neuropathic osteoarthropathy
Trial locations and contacts
No sites are listed yet.
About this 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.
Read the 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.
- Medical subject headings
- Peripheral Arterial Disease, Arterial Occlusive Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at the SOC index procedure
Secondary outcomes (4)
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: Measured at the standard of care (SOC) index procedure
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: Measured at the SOC index procedure
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: Measured at the SOC index procedure
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: Measured at the SOC index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedra Technology, PTE LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956523
- Sponsor's protocol ID
- CIP-003
- Acronym
- mini-TIME
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Tissue Monitoring During Endovascular Intervention Study
- ClinicalTrials.gov ID
- NCT04956523
- Acronym / sponsor ID
- mini-TIME / CIP-003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pedra Technology, PTE LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 data capture of the angiography utilized during the case. The study will enroll up to 20 subjects between the ages of 40 and 90 who are undergoing endovascular intervention for the management of their PAD. Sites to enroll approximately half of the subjects with primary "below the knee disease".
Key inclusion criteria (5 listed)
- The subject is undergoing endovascular intervention for the management of their PAD.
- The subject is between 40 to 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.
- 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)
Key exclusion criteria (6 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Measured at the SOC index procedure
To confirm that the Xauron system can be integrated into he angiography suite clinical workflow.
4 secondary outcomes
Relationship between interventional events of procedure and perfusion changed detected but the Xauron System
Time frame: Measured at the standard of care (SOC) index procedure
Relationship of perfusion data from different anatomical locations during procedure
Time frame: Measured at the SOC index procedure
User feedback from the team in the angiographic suite
Time frame: Measured at the SOC index procedure
Angiographic images to evaluate and understand perfusion monitoring
Time frame: Measured at the SOC index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Peripheral Artery Disease, run by Pedra Technology, PTE LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Moyer (610-509-6727, jmoyer@abioclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Measured at the SOC index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.