Peripheral Arterial DiseaseTRIAGENCT03163199
TRanslesIonal Assessment of Gradients During Endovascular Therapy
An observational study of Peripheral Arterial Disease and Fractional Flow Reserve, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Fractional Flow Reserve, Hemodynamics
- What is being tested?
- Translesional Hemodynamic Measurement
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 16 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with symptomatic peripheral arterial disease (critical limb ischemia or claudication)
Inclusions:
- Age >18 y/o, undergoing clinically indicated endovascular therapy (balloon angioplasty, stenting, atherectomy or combination) for lower extremity peripheral artery disease (PAD) and claudication or critical limb ischemia (CLI). Rutherford Category 2-6.
- Includes iliac lesions, common femoral, superficial femoral artery, popliteal artery and tibial vessels
- A subject can be enrolled more than once (up to a maximum of two total times) for treatment of a staged lesion but must wait at least 6 weeks from the completion of the last study enrollment.
Exclusions:
- No pregnant females
- No vulnerable populations (dementia, prisoners, children)
- Baseline bradycardia (heart rate <50 beats/min) or hypotension (systolic blood pressure <90 mm Hg) will be excluded from receiving adenosine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease.
Secondary objectives:
- Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy
- Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS
- Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs
- Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs
Read the detailed description
There are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. The present study will use the NAVVUS RXi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.
- Being tested
- Translesional Hemodynamic Measurement
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translesional Hemodynamic MeasurementDevice
Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures
Observational: • During treatment of Lesion a catheter is inserted into the diseased portion of the artery to remove the plaque and improve the blood flow through the artery. This measurement, which may be repeated 5 times during the treatment, to measure the blood flow at a point before and after the section of the artery with the blockage
Measured: At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start12 Apr 2017
- Primary completion1 Mar 2019
- Study completion16 Feb 2022
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Prasad, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163199
- Sponsor's protocol ID
- CTMS 14-0147-001
- Acronym
- TRIAGE
- Status last verified
- Feb 2022
- First submitted
- 11 Apr 2017
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRanslesIonal Assessment of Gradients During Endovascular Therapy
- ClinicalTrials.gov ID
- NCT03163199
- Acronym / sponsor ID
- TRIAGE / CTMS 14-0147-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 22 May 2017 (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.
Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease.
Secondary objectives:
- Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy
- Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS
- Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs
- Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs
Detailed description
There are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. The present study will use the NAVVUS RXi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with symptomatic peripheral arterial disease (critical limb ischemia or claudication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translesional Hemodynamic MeasurementMeasurement of hemodynamics using the NAVVUS catheter during endovascular therapy | Device | – |
Primary outcome
Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures
Time frame: At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure.
Observational: • During treatment of Lesion a catheter is inserted into the diseased portion of the artery to remove the plaque and improve the blood flow through the artery. This measurement, which may be repeated 5 times during the treatment, to measure the blood flow at a point before and after the section of the artery with the blockage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- 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.
Anand Prasad principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Fractional Flow Reserve, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures (time frame: At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the 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 18 Feb 2022.