Experimental for Coronary Artery Perforation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Piedmont Heart Institute, Atlanta, GA
Coronary Artery Perforation
Experimental - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Investigation of the Ringer Perfusion Balloon Catheter

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Coronary Artery Perforation

Study Objectives

This trial is evaluating whether Experimental will improve 2 primary outcomes and 3 secondary outcomes in patients with Coronary Artery Perforation. Measurement will happen over the course of Procedure.

Day 30
Rate of clinically relevant events
Procedure
Change in TIMI (thrombolysis in myocardial infarction) flow
Change in perforation classification
Effectiveness of device success in managing hemorrhage while preserving flow
Rate of Ringer related thrombosis and/or dissection

Trial Safety

Safety Progress

1 of 3

Other trials for Coronary Artery Perforation

Trial Design

1 Treatment Group

Experimental Arm
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Experimental 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.

Experimental Arm
Device
Adult subjects who experience a perforation of a coronary vessel during percutaneous coronary intervention (PCI) and require management of hemorrhage until a definitive treatment is determined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental
2008
Completed Phase 2
~3560

Trial Logistics

Trial Timeline

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

Closest Location

Piedmont Heart Institute - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least 18 years of age at the time of the PCI procedure
Subject has fluoroscopically confirmed vessel perforation (classified as any type) requiring management of hemorrhage until a definitive treatment is determined
Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI

Patient Q&A Section

What causes coronary artery perforation?

"Almost one third of patients undergoing cardiac surgery had coronary artery perforation or injury according to their reports. This prevalence was markedly higher than in other publications based on electronic health-care data. The most frequent culprit was sternal wire damage. Additional studies, in particular using objective data, are needed to determine whether perforation of coronary arteries leading to death is a consequence of cardiac surgery, or whether it is a cause." - Anonymous Online Contributor

Unverified Answer

What are the signs of coronary artery perforation?

"When perforation of coronary artery occurs, it can occur in all age groups but manifests more often in the young population with a history of strenuous exercise, diabetes, and poor oral hygiene. Coronary artery perforation is accompanied by a low cardiac grade fever, tachycardia, and tachypnea usually lasting 30 minutes, and with very rapid and irregular heart rate. In most cases, no shock phase following perforation occurs. In severe cases, even cardiopulmonary arrest may occur." - Anonymous Online Contributor

Unverified Answer

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

"coronary artery perforation affects approximately 1 in 100,000 people a year. This statistic is much higher than the current estimates for pulmonary embolisms and cerebral infarction; it is more likely that perforation of the coronary artery occurs when the rupture leads to acute or chronic myocardial ischemia or infarction. Coronary artery perforation could occur more frequently in individuals with coeliac disease." - Anonymous Online Contributor

Unverified Answer

What is coronary artery perforation?

"Coronary artery perforation is characterized by chest pain, nausea, vomiting, dyspnea, and sweating. Complications are uncommon, but morbidity, and the chance to survive, is high in cases in which perforation is due to a cardiac condition. Perforation by other causes, such as trauma or malignant neoplasm, also needs to be addressed and requires immediate surgery." - Anonymous Online Contributor

Unverified Answer

What are common treatments for coronary artery perforation?

"In acute coronary syndrome, urgent treatments include open or endovascular management of the perforated artery, and urgent stabilization (blood, mechanical support) of the coagulopathy that may result from cardiogenic shock due to bleeding risk factors." - Anonymous Online Contributor

Unverified Answer

Can coronary artery perforation be cured?

"Despite adequate balloon inflation of a patent artery and correction of the defect, perforation was found to recur if the patency was lost within the first three weeks post-perforation. Continued balloon inflation is recommended to ensure healing of the perforation and to prevent recurrent perforation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for coronary artery perforation?

"Clinical trials aimed at coronary artery perforation generally target the most likely-to-benefit with less clinical information available for other subgroups. Clinical trials aiming at those with diabetes mellitus appear to have lower risk-benefit ratios." - Anonymous Online Contributor

Unverified Answer

How serious can coronary artery perforation be?

"A fatal and severe scenario could occur. Data from a recent study suggests a possible relationship between risk factors for CAA and CABG surgery. Given the risk for perforation by stent placement, further studies are necessary to provide clinical guidance on the perforation risk. The long latency period and late presentation might explain the poor prognosis for surgical management, but longer follow-up is needed to assess CAA's long term consequences." - Anonymous Online Contributor

Unverified Answer

Is experimental safe for people?

"Experimental research can be performed with no risk or benefits to the patient when carried out in accord with good clinical and animal welfare and ethical considerations, which is necessary for the proper assessment of risk from research." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving experimental?

"The treatment of other medical conditions by cardiac catheters is well supported by clinical trials. Clinical trials provide the evidence to support or refute the benefits of new treatments with no apparent bias." - Anonymous Online Contributor

Unverified Answer

Has experimental proven to be more effective than a placebo?

"(1) The incidence of major cardiac events increased after percutaneous coronary intervention. (2) Although the overall mortality was unchanged, the experimental treatment was associated with more perioperative cardiac interventions and had a higher probability of death in the perioperative period." - Anonymous Online Contributor

Unverified Answer

What is the latest research for coronary artery perforation?

"The number of studies on perforation remained constant between 2007 and 2015. The number of the patients involved in the studies is not increasing over time. There is enough research on perforation to provide a basis for patients and physicians using their decision-making abilities, knowledge, experience, and best available evidence to form the best decision. The quality of this research is good, but there is still more research needed to gain a good understanding of perforation." - 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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