The PROSPECT II study was prompted by promising new data on the ability of the TVC Imaging System to detect large vulnerable plaques precisely at the coronary artery sites at which an ST-segment elevation myocardial infarction (STEMI) occurred causing a dangerous type of heart attack.
PROSPECT II is an investigator-initiated study led by co-principal investigators Gregg W. Stone, M.D., professor of medicine, Columbia University Medical Center and co-director, Medical Research & Education Division at the Cardiovascular Research Foundation in New York; and David Erlinge, M.D., Ph.D., director of the Department of Cardiology, Lund University, Skane University Hospital in Lund, Sweden. The Cardiovascular Research Foundation (CRF) will oversee the study and provide angiographic and intravascular imaging data core lab analysis and biostatistical analysis. The Uppsala Clinical Research Center will organize and coordinate the clinical management of the trial, including patient recruitment, monitoring and data collection. Patients will be recruited through the Swedish and Norwegian Coronary Angiography and Angioplasty Register (SWEDEHEART) and the corresponding register in Denmark.
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"The success of PROSPECT II would be a major step toward the goal of prospective identification and eventual treatment of the vulnerable plaques causing unanticipated coronary events," said Dr. Stone. "Thrombosis of vulnerable plaque is the leading cause of cardiac death, myocardial infarction and heart failure, which are debilitating and costly conditions. We look forward to implementing this groundbreaking study, which has the potential to change how we approach patients with coronary artery disease."
About Heart Disease
According to the Centers for Disease Control, heart disease is the leading cause of death for both men and women in the U.S., and 720,000 Americans experience a heart attack each year.2 Coronary artery disease is caused by the build-up of cholesterol, known as plaque, and other materials inside the walls of the coronary arteries. Over time, the accumulation of plaque can gradually reduce blood supply to the heart, leading to chest pain during exertion. In addition, the plaques may also rupture which can lead to a blood clot that causes a heart attack or sudden death.
About The TVC Imaging System™
The TVC Imaging System™ is a first-in-class intravascular imaging system that holds the potential to revolutionize the management of coronary artery disease by providing information that is critical for evaluating vessel structure and composition. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting. The device also enables cardiologists to predict peri-procedural heart attacks by assessing not only the degree of stenosis, but also the presence and extent of lipid-core plaques (LCP).
