Balloon Inflation Techniques for Coronary Artery Disease

(INFLATION/DE Trial)

Overseen By Kristin Miller, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Central Arkansas Veterans Healthcare System

Disqualifiers: Myocardial infarction, Occlusion, Instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the optimal method for inflating a balloon during stent placement in individuals with coronary artery disease. Researchers aim to compare prolonged inflation, where the balloon remains inflated longer, with rapid inflation, where it is quickly inflated and then deflated. The study employs a special imaging technique called OCT to assess stent placement accuracy. Candidates for this trial require a single stent and can benefit from this imaging to ensure proper placement. As an unphased trial, it provides patients the chance to contribute to innovative research that could enhance stent placement techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these balloon inflation techniques are safe for coronary artery disease?

Research has shown that keeping the balloon inflated longer during a procedure is safe and helps the stent fit better against the artery wall. A case study found that this method does not cause harm and improves stent placement.

Studies have also shown that quick inflation is safe. This method involves rapidly inflating and deflating the balloon to expand the stent. Research with special balloon types found this method effective and without major issues.

Both methods have undergone safety testing in various studies. Evidence indicates that both techniques are well-tolerated by patients and typically do not cause serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different balloon inflation techniques for treating coronary artery disease, a condition commonly managed with stent placements. The trial compares rapid and prolonged inflation methods to determine their effectiveness and safety. Unlike standard practices that may not specify inflation times or pressures, this trial investigates whether maintaining high pressure for specific durations can improve patient outcomes. By understanding these nuances, the trial aims to refine stent deployment, potentially leading to better heart health for patients.

What evidence suggests that these balloon inflation techniques are effective for coronary artery disease?

This trial will compare two balloon inflation techniques for coronary artery disease: prolonged inflation and rapid inflation. Research has shown that keeping the balloon inflated longer when placing a stent can lead to better results. In one study, this method worked well in 8 out of 11 cases, suggesting it helps the stent fit the artery better. Another study found that longer inflations can reduce artery narrowing and improve patient outcomes. While quick inflation is often used, little data directly compares it to the longer method. Overall, evidence suggests that keeping the balloon inflated longer might be more effective for ensuring the stent fits the artery walls properly. ^{6 7 8 9 10}

Who Is on the Research Team?

Barry F Uretsky, M.D.

Principal Investigator

Central Arkansas Veterans' Healthcare System

Are You a Good Fit for This Trial?

This trial is for adults over 18 with coronary artery disease who need a single stent placed in an artery that's 2.5-3.5 mm wide and can have OCT imaging done to check the stent's placement. It's not for those in shock, with severe kidney issues, certain heart attacks, completely blocked arteries, complex stenting needs or unable to consent.

Exclusion Criteria

I have had a severe type of heart attack.

I have a completely blocked artery.

My heart's artery has a branch larger than 2.5 mm in the area that was stented.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo stent deployment using either rapid or prolonged high-pressure balloon inflation

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stent deployment

1 hour post-procedure

Continuous monitoring during procedure

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged inflation
• Rapid inflation

Trial Overview The study compares two ways of putting a stent in: one uses prolonged high-pressure balloon inflation until pressure stabilizes (which could take several minutes), and the other uses rapid inflation/deflation (lasting about 15-30 seconds). The goal is to see which method better expands the stent against the artery wall.

How Is the Trial Designed?

Group I: Prolonged Experimental Treatment 1 Intervention

Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with \<0.3 atm drop during that period.

Group II: Rapid Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Central Arkansas Veterans Healthcare System

Lead Sponsor

Trials

24

Recruited

343,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39718636

Effectiveness of the repeated 3-time-balloon-inflation ... Although this method seems effective in avoiding excessive high-pressure dilation, its clinical data are insufficient. In this study, we ...

2. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(13)00004-X/fulltext

Outcome of prolonged balloon inflation for the ... Prolonged balloon inflations were effective for 8 cases out of 11 stent CPs, however, the ballooning duration was significantly longer than that in wire and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0019483225000987

Long term outcomes of drug-coated balloons versus ... The aim of this study was to assess angiographic efficacy and clinical outcomes of drug coated balloons (DCB) as compared with DES in SvCAD setting.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37855186/

Impact of prolonged drug-coated balloon inflation on ... Prolonged DCB inflation was associated with reduced residual stenosis and improved clinical outcomes in patients with coronary artery disease.

5. nature.com nature.com/articles/s41598-025-92052-2

Predictors of optimal angiographic lesion outcomes in ... Specifically, our data demonstrated that a 0.1 increase in the B-A ratio was associated with 43.2% increase in the odds of achieving favorable ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8815170/

A randomized controlled clinical trial of prolonged balloon ... First, a long balloon inflation time with low pressure could reduce the iatrogenic rupture of thin-cap fibroatheroma through stent expansion, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352407/

Drug-Coated Balloons for Coronary Interventions: A Focused ... The balloon coating properties offer advantages for drug release kinetics, adhesion properties, and overall efficacy. Coating features, such as ...

8. jacc.org jacc.org/doi/10.1016/j.jaccas.2019.11.026

Prolonged Balloon Inflation to Effect Full Stent Expansion ... The present case demonstrated that prolonged balloon inflation with POP can, in fact, be performed safely and allow for improved stent expansion ...

9. nature.com nature.com/articles/s41598-025-20488-7

Safety and efficacy of super-high pressure OPN balloon in ... In our image-guided study, we found that OPN usage may be a safe and effective in patients with ISR lesions leading to a very good acute luminal ...

10. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014064

Long-Term Outcomes Following Sirolimus-Coated Balloon ... In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of TLR, MI, all-cause death, and ...