Advocate Aurora Research Institute has joined two clinical trials that are evaluating an investigational balloon angioplasty device that is coated with a medication designed to prevent the formation of new blood vessel blockages in people with peripheral artery disease, or PAD.
Advocate Christ Medical Center in Oak Lawn and Advocate Lutheran General Hospital in Park Ridge are the first sites in Illinois to join the studies.
Approximately 6.5 million people ages 40 and older have PAD in the U.S., according to the Centers for Disease Control and Prevention.
“In people with peripheral artery disease and threatened limb loss, a buildup of plaque can narrow or even close the blood vessels in the leg, which reduces blood flow to the limb,” said interventional cardiologist and endovascular specialist Jaafer Golzar, MD, Advocate Christ’s site principal investigator for both studies. “These new technologies may help us improve outcomes in patients with PAD, improve amputation rates and improve long term durability of these procedures.”
Vascular surgeon Lewis Schwartz, MD, is Advocate Lutheran General’s site principal investigator for both studies.
To treat the narrowing of blood vessels that occurs in PAD, doctors typically insert a catheter containing a balloon angioplasty device through a small incision in the leg. The device is guided through the body’s chain of blood vessels until it reaches the narrowed region at which point the balloon is inflated in hopes of opening up the blood vessel and restoring proper blood flow.
The two studies, SELUTION4BTK (NCT05055297) and SELUTION4SFA (NCT05132361), will test the safety and effectiveness of a drug-eluting balloon angioplasty device. Called the SELUTION Sustained Limus Release (SLR)TM Drug-Eluting Balloon (DEB), the investigational device is similar to traditional treatment devices except that the surface is coated with a drug called Sirolimus, which may reduce the likelihood that the vessel narrows again afer an angioplasty.
“Balloon angioplasty has become the standard treatment for PAD, but its effects can sometimes be limited and short-lived,” said Laura Wrona, MSN, Director of the Research Institute’s Center of Excellence in Cardiovascular Research. “The insertion of a metal stent after balloon angioplasty to keep the blood vessel open has improved the procedure’s effectiveness, but stents can sometimes result in injuries to the blood vessel, all of which is why researchers are looking for new treatment methods for PAD.”
SELUTION4BTK will investigate the device in people with an advanced stage of PAD called chronic limb-threatening ischemia that is below the knee. SELUTION4SFA will investigate the device in people with PAD in the superficial femoral artery, a major blood vessel in the thigh, and the proximal popliteal artery, an extension of the superficial femoral artery that is located in the back of the knee.
Researchers plan to enroll 376 participants in SELUTION4BTK and 300 participants in SELUTION4SFA.
The clinical trials are sponsored by MedAlliance, LLC, manufacturer of the study device.
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