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Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient

NCT02387658 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2018-09-12

No results posted yet for this study

Summary

1. To perform an observational analysis to determine if mean translesional gradient measurements (TLG) are associated with differences in clinical outcomes in patients with femoropopliteal arterial disease and claudication.
2. Hypothesis: Patients stratified by a residual translesional gradient \</= 11 mmHg after peripheral revascularization or angiography alone will have better clinical outcomes than patients with TLG \> 11 mmHg as assessed by six minute walk (6MW), walking impairment questionnaire scores (WIQ), ankle brachial index and need for repeat procedure at 6 months.

Conditions

  • Peripheral Arterial Disease
  • Claudication

Interventions

PROCEDURE

translesional gradient measurement

Patients will be stratified into two groups based on the final mean translesional pressure gradient obtained in the femoropopliteal arterial bed after revascularization or just after angiography if no revascularization is done.

Sponsors & Collaborators

  • North Texas Veterans Healthcare System

    lead FED

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-06
Primary Completion
2016-07-13
Completion
2016-07-13

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 NCT02387658 on ClinicalTrials.gov