TRanslesIonal Assessment of Gradients During Endovascular Therapy

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

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Fractional Flow Reserve Hemodynamics Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Translesional Hemodynamic Measurement

Device

Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Acronym: TRIAGE

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2022
First posted: May 22, 2017
Registry last updated: Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed