TRanslesIonal Assessment of Gradients During Endovascular Therapy

Completed

• Conditions: Hemodynamics; Fractional Flow Reserve; Peripheral Arterial Disease

• Registration Number: NCT03163199
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Study Timeline

• Study First Submitted: 2017-04-11
• Study Start: 2017-04-12
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Primary Completion: 2019-03-01
• Status Verified: 2022-02
• Study Completion: 2022-02-16
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures	At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure.	Observational: • During treatment of Lesion a catheter is inserted into the diseased portion of the artery to remove the plaque and improve the blood flow through the artery. This measurement, which may be repeated 5 times during the treatment, to measure the blood flow at a point before and after the section of the artery with the blockage

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States