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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-procedure and first hour post-pci

Awards & highlights

INFLATION/DE Trial 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.Check my eligibility

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.See study design

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.

INFLATION/DE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 within first hour after stent deployment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 within first hour after stent deployment

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 within first hour after stent deployment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Minimal lumen stent diameter

Minimal luminal stent area

Number of unapposed stent struts

Secondary outcome measures

% of patients with complete stent apposition

Number of unapposed stent struts/mm of stent

Cardiac Arrhythmia

+1 more

INFLATION/DE 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.

Do I qualify?Apply below to find out