Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation

Study Overview
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Brief Summary
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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.

Official Title
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Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation on the Results of Stent Deployment

Conditions
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Coronary Artery Disease, Coronary Stent Occlusion

Intervention / Treatment
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* Other: Prolonged inflation
* Other: Rapid inflation


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rapid<br>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. | Other: Rapid inflation<br>* 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.<br>|
| Experimental: Prolonged<br>Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period. | Other: Prolonged inflation<br>* Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unapposed stent struts |  | Day 1 Within first hour after after stent deployment | 
| Minimal luminal stent area |  | Day 1 Within first hour after after stent deployment | 
| Minimal lumen stent diameter |  | Day 1 Within first hour after after stent deployment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unapposed stent struts/mm of stent |  | Day 1 Within first hour after stent deployment | 
| % of patients with complete stent apposition |  | Day 1 Within first hour after stent deployment | 
| Symptomatic ischemia requiring balloon deflation |  | Intra-procedure | 
| Serious arrhythmia |  | Intra-procedure and first hour post-PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stents, angioplasty, balloon, coronary, coronary artery stenosis, optical coherence tomography