Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation (INFLATION/DE)

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Stent Occlusion
• Intervention / Treatment: Other: Rapid inflation; Other: Prolonged inflation

Detailed Description

The rapid inflation method (termed rapid) will consist of reaching a high-pressure (16 atmospheres)with the stent-deployment balloon and maintaining it the duration of time determined by the operator but <30 sec if the balloon is fully deflated and longer only if the balloon requires a longer duration to become fully inflated. Based on previous data, the average time will likely be in the 20-30 sec range. Prolonged inflation (termed prolonged) will be performed at high pressure (16 atmospheres) and maintained for 30 sec with <0.3 atmospheres drop during that period. For example, in the case of 16 atmospheres, the prolonged inflation will require a steady pressure of 15.8-16 atmospheres for at least 30 sec. If the inflation pressure falls 0.3 further pressure will be applied using the digital inflation device until it is again at the target pressure, resetting the 30 second clock. It should be emphasized that if at any time during prolonged inflation there is hemodynamic or electrocardiographic instability, the balloon will be deflated. Based on our previous experience we do not anticipate any safety issues; however, we will measure safety parameters as noted below. After either the rapid or prolonged inflation, an OCT run will be performed to delineate stent expansion and strut apposition. Should the operator determine that the OCT appearance of the stent is unsatisfactory, it is left to the operator to proceed as clinically required, using any further approaches, as he or she sees fit. The results of any further intervention, however, will not be included as part of the data analysis. The study period consists of randomization through the end of the coronary intervention within the catheterization laboratory, for both the efficacy and safety endpoint. The study period will be monitored continuously by a research coordinator and an investigator. All adverse events as described under Safety end points will be reported to the Institutional Review Board (IRB) as per the IRBs prescribed time frame.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Miller, RN; Phone Number: 501-257-5893; Email: kristin.miller4@va.gov

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • John L. McClellan Memorial Veterans Hospital
      • Principal Investigator: Barry F Uretsky, MD
      • Contact: Kristin Miller, RN; Phone Number: 501-257-5893; Email: kristin.miller4@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unopposed stent struts	How many stents are unopposed	Day 1 Within first hour after after stent deployment
Minimal luminal stent area	Minimal area of the luminal stent area measured	Day 1 Within first hour after after stent deployment
Minimal lumen stent diameter	Diameter measured	Day 1 Within first hour after after stent deployment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unopposed stent struts/mm of stent	How many unopposed stent struts are involved	Day 1 Within first hour after stent deployment
% of patients with complete stent apposition	percentage of patients measured that have a complete stent apposition	Day 1 Within first hour after stent deployment
Symptomatic ischemia requiring balloon deflation	ischemia requiring balloon deflation	Intra-procedure
Serious arrhythmia	Serious arrhythmia during intervention	Intra-procedure and first hour post-Percutaneous Coronary Intervention (PCI)

Collaborators and Investigators

• Sponsor: Central Arkansas Veterans Healthcare System
• Investigators: Principal Investigator: Barry F Uretsky, M.D., Central Arkansas Veterans' Healthcare System

Publications and helpful links

General Publications

• Cook JR, Mhatre A, Wang FW, Uretsky BF. Prolonged high-pressure is required for optimal stent deployment as assessed by optical coherence tomography. Catheter Cardiovasc Interv. 2014 Mar 1;83(4):521-7. doi: 10.1002/ccd.24724. Epub 2013 Feb 21.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimated): September 30, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: optical coherence tomography; stents; coronary artery stenosis; angioplasty, balloon, coronary
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 287332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Individual Participant Data (IPD) sharing plan at this time as the study has been placed on hold.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No