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TRanslesIonal Assessment of Gradients During Endovascular Therapy

NCT03163199 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2022-02-18

No results posted yet for this study

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

Interventions

DEVICE

Translesional Hemodynamic Measurement

Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Anand Prasad · UT Health San Antonio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2019-03-01
Completion
2022-02-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163199 on ClinicalTrials.gov