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 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.

Study Overview

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

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

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • John L. McClellan Memorial Veterans Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• Masking: NONE

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	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	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

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 (ANTICIPATED): January 1, 2024
• Primary Completion (ANTICIPATED): December 1, 2028
• Study Completion (ANTICIPATED): December 1, 2028

Study Registration Dates

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

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

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

Drug and device information, study documents

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