YRMC announces clinical trial for artery disease
Treatment option could help future patients
Many people are aware of the fact that medication and medical devices must be approved by the Food and Drug Administration (FDA) for patients, but many may not consider the trials that have to be completed before that approval is obtained.
About four years ago, clinical research studies started taking place at Yuma Regional Medical Center. Clinical Research Coordinator Yesenia Zambrano says that she truly admires the selflessness of research participants.
“When I used to consent participants in various trials what I loved is their altruism,” Zambrano said. “They will say and share with me at different time points the same message: ‘If it won’t benefit me, I still want to continue to see how it’s going to benefit others.’ That is what drives medicine.”
Recently, YRMC announced the first usage of the new treatment option for patients suffering from peripheral artery disease (PAD) or critical limb ischemia (CLI).
PAD is a disease of the blood vessels in the legs and feet that occurs when arteries become narrow or clogged and do not receive enough blood flow to meet the body’s needs.
Furthermore, when left untreated, PAD can lead to CLI, a more serious form the disease, the hospital release states. YRMC health officials noted that while patients with CLI experience similar symptoms to PAD patients, CLI symptoms can significantly increase in severity from pain while resting, to open sores, to life-threatening conditions like gangrene, and can eventually require limb amputation in some patients.
Clogged arteries in the legs, like clogged arteries in
the heart, can put individuals at risk for heart attack or stroke, according to the U.S. Department of Health and Human Services.
The option is called the Tack Endovascular System, and the technology is now available to patients who qualify for the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical study at the hospital, which began about 30 days ago.
According to the release, the TOBA II BTK study is designed to enroll 232 subjects at up to 50 global sites. To be a part of the program, all research participants need to be suffering from advanced PAD or critical limb ischemia.
In total, Trudy Milner, Administrative Director of Institutional Research, says there are 17 clinical research studies at YRMC, with about 10 active studies in oncology (the study and treatment of tumors) and six in cardiology. She noted that the hospital is also being courted by additional device and pharmaceutical companies.
Sarah Medina-Rordriguez, Director of Institutional Research, says she feels part of the reason that YRMC is being courted is their “very engaged principal investigators.”
“A principal investigator is the person who is the designated doctor in charge to run the trial,” Medina-Rodriguez said. “A trial can also have sub-investigators to assist in helping provide the right treatment for the participant who would not otherwise have that option because all these medications or devices are not yet FDA (Federal Drug Administration) approved. That is what a clinical trial is.”
Milner noted that the participation in Yuma is high given its size.
“I think it’s important to underscore that this program (is) about four years old now — all the clinical trials. What is striking about it is the success that we’ve had for a community hospital. Both Sarah and I come from large academic medical centers where you have all kinds of teaching and research going on.”
“It’s really a credit to the institution that we are able to have been first selected and have an opportunity to participate and successfully run these kinds of trials,” Milner added. “What it means is we are not only contributing to science and a knowledge base, but we are providing something to the people of our community that otherwise they