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Balloon Inflation Techniques for Coronary Artery Disease (INFLATION/DE Trial)

N/A

Waitlist Available

Led By Barry F Uretsky, M.D.

Research Sponsored by Central Arkansas Veterans Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

ST segment elevation myocardial infarction

Chronic total occlusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether prolonged balloon inflation or rapid inflation/deflation is more effective in deploying a coronary balloon-expandable stent.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this procedure-focused trial, potential risks may include discomfort at the inflation site, bleeding complications from prolonged pressure application or vessel damage due to overexpansion.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a severe type of heart attack.

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I have a completely blocked artery.

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

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I do not have a condition causing very low blood pressure due to heart problems.

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I am unable to understand and give consent for treatment.

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I have a blockage in the main artery of my heart.

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My kidney function is low with creatinine over 1.8 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ProlongedExperimental Treatment1 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: RapidActive Control1 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.

0 / 7Eligibility criteria met