Coronary Artery DiseaseINFLATION/DENCT01952873
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
A study testing Prolonged inflation and Rapid inflation in people with Coronary Artery Disease and Coronary Stent Occlusion, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stent Occlusion
- What is being tested?
- Prolonged inflation and Rapid inflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
John L. McClellan Memorial Veterans Hospital
Little Rock, Arkansas, 72205
Kristin Miller, RN, 501-257-5893, kristin.miller4@va.gov
Barry F Uretsky, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Stent Occlusion
- Being tested
- Prolonged inflation, Rapid inflation
- Keywords
- stents, angioplasty, balloon, coronary, coronary artery stenosis, optical coherence tomography
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged inflationOther
Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period.
Rapid inflationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rapid | Active comparator | 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. Receives: Other: Rapid inflation |
| Prolonged | Experimental | Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period. Receives: Other: Prolonged inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unopposed stent struts
How many stents are unopposed
Measured: Day 1 Within first hour after after stent deployment
Minimal luminal stent area
Minimal area of the luminal stent area measured
Measured: Day 1 Within first hour after after stent deployment
Minimal lumen stent diameter
Diameter measured
Measured: Day 1 Within first hour after after stent deployment
Secondary outcomes (4)
Number of unopposed stent struts/mm of stent
How many unopposed stent struts are involved
Measured: Day 1 Within first hour after stent deployment
% of patients with complete stent apposition
percentage of patients measured that have a complete stent apposition
Measured: Day 1 Within first hour after stent deployment
Symptomatic ischemia requiring balloon deflation
ischemia requiring balloon deflation
Measured: Intra-procedure
Serious arrhythmia
Serious arrhythmia during intervention
Measured: Intra-procedure and first hour post-Percutaneous Coronary Intervention (PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Barry F Uretsky, M.D., Principal investigator, Central Arkansas Veterans' Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952873
- Sponsor's protocol ID
- 287332
- Acronym
- INFLATION/DE
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2013
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Individual Participant Data (IPD) sharing plan at this time as the study has been placed on hold.
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.
PubMed 23436559
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation on the Results of Stent Deployment
- ClinicalTrials.gov ID
- NCT01952873
- Acronym / sponsor ID
- INFLATION/DE / 287332
- Conditions
- Coronary Artery Disease, Coronary Stent Occlusion
- Keywords
- stents, angioplasty, balloon, coronary, coronary artery stenosis, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid | Active comparator | Other: Rapid inflationThe 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. |
| Prolonged | Experimental | Other: Prolonged inflationProlonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged inflationProlonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period. | Other | Prolonged |
| Rapid inflationThe 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 |
Primary outcome
Number of unopposed stent struts
Time frame: Day 1 Within first hour after after stent deployment
How many stents are unopposed
Minimal luminal stent area
Time frame: Day 1 Within first hour after after stent deployment
Minimal area of the luminal stent area measured
Minimal lumen stent diameter
Time frame: Day 1 Within first hour after after stent deployment
Diameter measured
4 secondary outcomes
Number of unopposed stent struts/mm of stent
Time frame: Day 1 Within first hour after stent deployment
% of patients with complete stent apposition
Time frame: Day 1 Within first hour after stent deployment
Symptomatic ischemia requiring balloon deflation
Time frame: Intra-procedure
Serious arrhythmia
Time frame: Intra-procedure and first hour post-Percutaneous Coronary Intervention (PCI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 23436559Cook 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.
- Individual participant dataSharing planned: No. No Individual Participant Data (IPD) sharing plan at this time as the study has been placed on hold.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barry F Uretsky, M.D. principal investigator
Central Arkansas Veterans' Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged inflation and Rapid inflation in people with Coronary Artery Disease and Coronary Stent Occlusion, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Miller, RN (501-257-5893, kristin.miller4@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unopposed stent struts (time frame: Day 1 Within first hour after after stent deployment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.