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NCT02387658 · ClinicalTrials.gov registry record
Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient
A clinical trial, sponsored by North Texas Veterans Healthcare System.
- Completed
- Registry status
- 25
- Enrollment target
NCT02387658: Completed study, sponsored by North Texas Veterans Healthcare System.
NCT02387658 is a clinical trial that has completed, run by North Texas Veterans Healthcare System. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02387658 has completed, sponsored by North Texas Veterans Healthcare System.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
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.
Primary Outcome
Compare change in six minute walk distance at 2 weeks post angiography +/- revascularization to distance walked at 6 months +/- 15 days between patients stratified by a residual mean translesional gradient \> 11 mmHg or \</= 11 mmHg. The six minute walk test involves walking in a straight 100m hallway back and forth for as far as possible during a six minute time span.
Interventions
- PROCEDURE translesional gradient measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-02-06 |
| Est. Completion | 2016-07-13 |
What the finished NCT02387658 record still lists
NCT02387658 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which translesional gradient measurement is the first listed.
NCT02387658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02387658 about?
NCT02387658 is a clinical study titled "Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient". 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 \</=...
What is the current status of trial NCT02387658?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2015-02-06. Estimated completion is 2016-07-13.
What interventions are being tested in trial NCT02387658?
The interventions under investigation include: translesional gradient measurement (PROCEDURE).
Who is sponsoring clinical trial NCT02387658?
This trial is sponsored by North Texas Veterans Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.
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