TRanslesIonal Assessment of Gradients During Endovascular Therapy

NCT03163199•The University of Texas Health Science Center at San Antonio

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Locations (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

April 12, 2017

Primary Completion Date

March 1, 2019

Completion Date

February 16, 2022

Last Updated

February 18, 2022

Enrollment

ACTUAL participants

Conditions

Peripheral Arterial DiseaseFractional Flow ReserveHemodynamics

Interventions

Translesional Hemodynamic Measurement

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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TRanslesIonal Assessment of Gradients During Endovascular Therapy

Inclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

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