TRanslesIonal Assessment of Gradients During Endovascular Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2018 |
| Start Date: | April 12, 2017 |
| End Date: | March 1, 2019 |
| Contact: | Anand Prasad, MD |
| Email: | prasada@uthscsa.edu |
| Phone: | 2105674602 |
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
(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
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.
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.
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
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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