Balloon Inflation Techniques for Coronary Artery Disease
(INFLATION/DE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 inflation/deflation sequence when performed to the same balloon inflation pressure.
Who Is on the Research Team?
Barry F Uretsky, M.D.
Principal Investigator
Central Arkansas Veterans' Healthcare System
Are You a Good Fit for This Trial?
This trial is for adults over 18 with coronary artery disease who need a single stent placed in an artery that's 2.5-3.5 mm wide and can have OCT imaging done to check the stent's placement. It's not for those in shock, with severe kidney issues, certain heart attacks, completely blocked arteries, complex stenting needs or unable to consent.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo stent deployment using either rapid or prolonged high-pressure balloon inflation
Follow-up
Participants are monitored for safety and effectiveness after stent deployment
What Are the Treatments Tested in This Trial?
Interventions
- Prolonged inflation
- Rapid inflation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Central Arkansas Veterans Healthcare System
Lead Sponsor