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

Coronary Artery Disease Clinical Trial

— INFLATION/DE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01952873
• Other study ID #: 287332
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2028

Study information

• Verified date: February 2023
• Source: Central Arkansas Veterans Healthcare System
• Contact: Kristin Miller, RN
• Phone: 501-257-5893
• Email: kristin.miller4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stent Occlusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	John L. McClellan Memorial Veterans Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Central Arkansas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unapposed stent struts		Day 1 Within first hour after after stent deployment
Primary	Minimal luminal stent area		Day 1 Within first hour after after stent deployment
Primary	Minimal lumen stent diameter		Day 1 Within first hour after after stent deployment
Secondary	Number of unapposed stent struts/mm of stent		Day 1 Within first hour after stent deployment
Secondary	% of patients with complete stent apposition		Day 1 Within first hour after stent deployment
Secondary	Symptomatic ischemia requiring balloon deflation		Intra-procedure
Secondary	Serious arrhythmia		Intra-procedure and first hour post-PCI