Boston Scientific of Marlborough has launched a trial of a coronary stent system to get more information about the product’s use in underserved populations, including women and people of color, the company announced Monday.
The company has begun the trial that will include up to 1,500 patients from understudied populations. The study will take place at up to 65 U.S. sites and examine use of the stent system in women, African-Americans, Latinos and Hispanics and American Indians or Alaska Natives. Historically, large-scale clinical trials in cardiology have had a disproportionately low inclusion of women and non-white patients, according to Boston Scientific.
“The number of minority and female patients participating in clinical trials is often not representative of disease epidemiology,” Dr. Wayne Batchelor, co-principal investigator for the study, said in a statement. “Since different populations may respond differently to various therapies, it is important that we generate data to help clinicians make evidence-based treatment decisions for all patients.”
The trial will use the company’s Promus PREMIER Stent System, which is approved by the U.S. Food and Drug Administration (FDA) to treat coronary artery disease.
