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.
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"(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
"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