CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
translesional gradient measurementprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02387658
NCT02387658N/ACompleted

Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient

North Texas Veterans Healthcare System·observational·Posted Mar 13, 2015·Updated Sep 12, 2018

In Brief

An observational study evaluating translesional gradient measurement for Peripheral Arterial Disease and Claudication. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 13, 2015
Enrollment StartFeb 6, 2015
Primary CompletionJul 13, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.3 years ago

Interventions

translesional gradient measurementprocedure

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.