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NCT03163199 · ClinicalTrials.gov registry record
TRanslesIonal Assessment of Gradients During Endovascular Therapy
A clinical trial, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- 22
- Enrollment target
NCT03163199: Completed study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT03163199 is a clinical trial that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03163199 has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
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
Primary Outcome
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
Interventions
- DEVICE Translesional Hemodynamic Measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-04-12 |
| Est. Completion | 2022-02-16 |
What the finished NCT03163199 record still lists
NCT03163199 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Translesional Hemodynamic Measurement is the first listed.
NCT03163199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03163199 about?
NCT03163199 is a clinical study titled "TRanslesIonal Assessment of Gradients During Endovascular Therapy". 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 th...
What is the current status of trial NCT03163199?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2017-04-12. Estimated completion is 2022-02-16.
What interventions are being tested in trial NCT03163199?
The interventions under investigation include: Translesional Hemodynamic Measurement (DEVICE).
Who is sponsoring clinical trial NCT03163199?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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