TRanslesIonal Assessment of Gradients During Endovascular Therapy (TRIAGE)

The University of Texas System (UT)

Status: Completed

Conditions: Fractional Flow Reserve; Peripheral Arterial Disease; Hemodynamics

Treatments: Device: Translesional Hemodynamic Measurement

Study type: Observational

Funder types: Other

Identifiers

NCT03163199

CTMS 14-0147-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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