Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2014 |
| End Date: | October 2015 |
| Contact: | Kristin Miller, RN |
| Email: | kristin.miller4@va.gov |
| Phone: | 501-257-5893 |
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation on the Results of Stent Deployment
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
apposition 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.
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
apposition 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.
Inclusion Criteria:
Patients >18 years old with coronary disease with clinical indication for single stent
placement in a lesion with a 2.5-3.5 mm diameter and who require OCT for determination of
effective stent placement .
Exclusion Criteria:
1. ST segment elevation myocardial infarction 2. Chronic total occlusion 3. Bifurcation
lesion or major side branch (>2.5 mm) within the stented area 4. Need for overlapping
stents 5. Clinical instability including cardiogenic shock 6. Inability to give informed
consent 7. Chronic kidney disease with serum creatinine >1.8 mg/dL 8. Unprotected left
main stenosis
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