Balloon Inflation Techniques for Coronary Artery Disease
(INFLATION/DE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBarry F Uretsky, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Central Arkansas Veterans Healthcare System

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18, have coronary disease, and need a stent for a 2.5-3.5 mm lesion.

Exclusion Criteria

I have had a severe type of heart attack.

I have a completely blocked artery.

My heart's artery has a branch larger than 2.5 mm in the area that was stented.

+5 more

Participant Groups

The study compares two ways of putting a stent in: one uses prolonged high-pressure balloon inflation until pressure stabilizes (which could take several minutes), and the other uses rapid inflation/deflation (lasting about 15-30 seconds). The goal is to see which method better expands the stent against the artery wall.

2Treatment groups

Experimental Treatment

Active Control

Group I: ProlongedExperimental Treatment1 Intervention

Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with \<0.3 atm drop during that period.

Group II: RapidActive Control1 Intervention

The rapid inflation method will consist of reaching an operator determined high-pressure (16 atm) with the stent-deployment balloon and maintaining it the duration of time determined by the operator but \<30 sec if the balloon is fully inflated and longer only if the balloon requires a longer duration to become fully inflated.