TRanslesIonal Assessment of Gradients During Endovascular Therapy

Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:April 12, 2017
End Date:March 1, 2019
Contact:Anand Prasad, MD

Use our guide to learn which trials are right for you!

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

- Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and

- Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional)
and TLPGs

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.


- 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.


- 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
We found this trial at
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
San Antonio, TX
Click here to add this to my saved trials