TRanslesIonal Assessment of Gradients During Endovascular Therapy

NCT03163199 | Completed FDA Device

• 1 other identifier: CTMS 14-0147-001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Arterial Disease; Fractional Flow Reserve; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Translesional Hemodynamic Measurement DEVICE

Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with symptomatic peripheral arterial disease (critical limb ischemia or claudication)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Anand Prasad

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: May 22, 2017
• Study Start: April 12, 2017
• Primary Completion: March 1, 2019
• Study Completion: February 16, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)