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NCT01952873 · ClinicalTrials.gov registry record · NA
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
A NA study, sponsored by Central Arkansas Veterans Healthcare System.
- Not yet
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01952873 is a NA study that has not yet begun recruiting, run by Central Arkansas Veterans Healthcare System. The registered enrollment target is 40 participants.
The verdict
NCT01952873, a NA study, has not yet begun recruiting, sponsored by Central Arkansas Veterans Healthcare System.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
It is universally accepted that high-pressure balloon inflation is required to most effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor are there any guidelines regarding the method of balloon inflation, particularly the duration of inflation. Underexpansion and strut malapposition after stent deployment are among the most powerful predictors for adverse vessel outcomes. High-pressure inflation for stent deployment is effective to optimally expand the stent, but unlike in vitro testing in air, there are poorly distensible plaque elements that may not instantaneously yield to the balloon pressure. However, these elements may ultimately yield to prolonged inflation. Most clinical interventional cardiologists inflate for a relatively short period (15-30 sec). The investigators have noted that when balloon pressure is maintained at a certain pressure level it tends to decrease over time, and may require 60-180 or more seconds to maintain pressure stability. This finding implies that plaque elements are yielding slowly over time to the increased pressure, thus increasing expansion, and suggests that a prolonged inflation until balloon pressure stabilizes is more effective than a rapid inflation/deflation sequence to fully expand and appose the stent to the vessel wall. At present there is no consensus on stent deployment strategy. It is our hypothesis that prolonged inflation is superior to the more commonly used strategy of rapid inflation/deflation. Optimal coherence tomography (OCT), a novel technology that measures near-infrared light reflections and translates them into a 2D image, has an axial resolution nearly 10-times that of intravascular ultrasound (IVUS). Thus it is possible to examine the extent of stent malposition and stent expansion using this modality. The current randomized trial tests the hypothesis that prolonged balloon inflation until a stable balloon pressure is maintained is more effective than a rapid infl
Interventions
- OTHER Prolonged inflation
- OTHER Rapid inflation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2027-01 |
| Est. Completion | 2028-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01952873
The ClinicalTrials.gov registry entry for NCT01952873 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Central Arkansas Veterans Healthcare System, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prolonged inflation is the first listed.
NCT01952873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01952873 about?
NCT01952873 is a clinical study titled "Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation". It is universally accepted that high-pressure balloon inflation is required to most effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor are there any guidelines regarding the method of balloon inflation, particularly the duration of inflation. Underexpansion a...
What is the current status of trial NCT01952873?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2027-01. Estimated completion is 2028-12.
What interventions are being tested in trial NCT01952873?
The interventions under investigation include: Prolonged inflation (OTHER), Rapid inflation (OTHER).
Who is sponsoring clinical trial NCT01952873?
This trial is sponsored by Central Arkansas Veterans Healthcare System, which has 9 total clinical trials registered on ClinicalTrials.gov.
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