NCT03163199

TRanslesIonal Assessment of Gradients During Endovascular Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease
• Fractional Flow Reserve
• Hemodynamics

Interventions

Type	Name	Description
DEVICE	Translesional Hemodynamic Measurement	Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy

Timeline

• Start date: 2017-04-12
• Primary completion: 2019-03-01
• Completion: 2022-02-16
• First posted: 2017-05-22
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study