Prolonged inflation for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Coronary Artery Disease+1 More
Prolonged inflation - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

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Eligible Conditions

  • Coronary Artery Disease
  • Coronary Stent Occlusion

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Coronary Artery Disease

Study Objectives

This trial is evaluating whether Prolonged inflation will improve 3 primary outcomes and 4 secondary outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of Day 1 Within first hour after after stent deployment.

Day 1
Minimal lumen stent diameter
Minimal luminal stent area
Number of unapposed stent struts
Day 1
% of patients with complete stent apposition
Number of unapposed stent struts/mm of stent
Intra-procedure
Symptomatic ischemia requiring balloon deflation
Intra-procedure and first hour post-PCI
Serious arrhythmia

Trial Safety

Safety Progress

1 of 3

Other trials for Coronary Artery Disease

Trial Design

2 Treatment Groups

Rapid
1 of 2
Prolonged
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Prolonged Inflation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intra-procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly intra-procedure for reporting.

Closest Location

John L. McClellan Memorial Veterans Hospital - Little Rock, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 .

Patient Q&A Section

What are the common side effects of prolonged inflation?

"It is important for physicians to be aware that there is significant risk for the development of pneumothorax, rib fractures, and increased bleeding after prolonged inflation." - Anonymous Online Contributor

Unverified Answer

How does prolonged inflation work?

"Recent findings demonstrates a new technique for prolonged chest wall inflation that may facilitate hemostasis and prevention of pulmonary embolism for patients requiring major chest surgery." - Anonymous Online Contributor

Unverified Answer

What are the signs of coronary artery disease?

"Most of the signs of CAD are non-specific and are not specific to CAD. It should, therefore, be determined in the clinical context which signs of CAD most commonly occur in this cohort." - Anonymous Online Contributor

Unverified Answer

What is coronary artery disease?

"Coronary artery disease consists of two conditions: stable angina (heart attack) and unstable angina. The first is a heart muscle attack and the second is a heart attack of insufficient oxygen supply to the heart muscle. Patients may experience coronary artery disease before being diagnosed with a heart attack. Often, patients have no symptoms before experiencing the acute heart attack. Patients are at greater risk after the sudden heart attack with more chest pains and palpitations. A cardiac catheterization is needed if coronary artery disease is suspected. Coronary artery disease affects an estimated 5 million people every year, of whom half are women. This is a large number of people with coronary artery disease that have not yet been diagnosed." - Anonymous Online Contributor

Unverified Answer

What causes coronary artery disease?

"CAD is a complex disease that has multiple causes, but many of these conditions can be prevented. The best way to prevent CAD is to abstain from smoking, exercise regularly, and eat a healthy diet." - Anonymous Online Contributor

Unverified Answer

What are common treatments for coronary artery disease?

"coronary artery disease is caused by a complex interplay of genetic and environmental influences. Some of these influences can be modified through dietary, stress, exercise, or social influences. While coronary artery disease-associated risk factors are well understood, many questions remain unanswered relating to optimal management for individuals who are diagnosed with the disease. The aim of this article is to discuss aspects of optimal management of coronary artery disease in a conceptual manner based on existing evidence from a systemic literature review and on knowledge gained from the clinical experience of the authors." - Anonymous Online Contributor

Unverified Answer

How many people get coronary artery disease a year in the United States?

"In a recent study, findings shows that the number of cases of CAD has fluctuated for decades. In the last few years the number of new cases has decreased and the proportion of patients with CAD and stroke who are unaware of the condition have declined." - Anonymous Online Contributor

Unverified Answer

Can coronary artery disease be cured?

"There is a high proportion of asymptomatic patients with CAD in our population, and CAD was associated with high-risk factors. In a small proportion of patients with known or suspected CAD, surgery was feasible, but further treatment with PCI, CABG or ACEI was not feasible." - Anonymous Online Contributor

Unverified Answer

Has prolonged inflation proven to be more effective than a placebo?

"This article reviewed the literature to determine whether prolonged inhalation inflation reduces ischemic complications associated with PCI in all revascularization patients. No evidence was found to support the use of prolonged inflation to increase the time the balloon is inflated prior to removing it. There is no evidence to support this technique. Nevertheless, inflation continues to remain an optimal therapeutic adjunct during PCI for all revascularization patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for coronary artery disease?

"While there are hundreds of studies being done, only a few are relevant for coronary disease, leading to limited recommendations based on evidence. There are many strategies that can help in coronary disease treatment, including physical activities and drugs therapy as lifestyle modification. There are also many medications that can help patients with angina. Many medications can prevent heart attack and help patients to reduce risks or risk of coronary artery disease. It is important for patients to understand what are the most current treatments for coronary disease, which ones are effective, and what the risks of these treatments are, as any risks is important to be taken into consideration." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for coronary artery disease?

"Individuals with established coronary disease and/or myocardial infarction and with stable heart failure or congestive heart failure are eligible for coronary artery disease clinical trials. As of 2009, no trial has demonstrated superior outcomes when targeted to these groups. Inclusion criteria for clinical trials should include age 60 and older." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in prolonged inflation for therapeutic use?

"PTA balloon inflation has become an accepted treatment option due to the many benefits, such as improved coronary blood flow, prevention of thrombosis, and improved myocardial functioning and preservation. While a prolonged balloon inflation is most effective for balloon-only PCI, we have expanded the indications of PTA by incorporating the use of a longer inflation time. In a case with multivessel coronary arterial disease, a prolonged PTA inflation is also feasible and has the additional benefit of suppressing the clotting reaction during balloon inflation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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