TRanslesIonal Assessment of Gradients During Endovascular Therapy

Peripheral Arterial Disease Clinical Trial

— TRIAGE  

Official title:

TRanslesIonal Assessment of Gradients During Endovascular Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163199
• Other study ID #: CTMS 14-0147-001
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: February 16, 2022

Study information

• Verified date: February 2022
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 16, 2022
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractional Flow Reserve
• Hemodynamics
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Translesional Hemodynamic Measurement
Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures	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	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.