Advocate Christ Medical Center in Chicago and Aurora St. Luke’s Medical Center in Milwaukee are two of the first few sites in the Midwest and among a select few in the world to offer a new international clinical trial evaluating an investigational device for treatment of blocked blood vessels in the lower leg, below the knee.
This condition, known as critical limb ischemia (CLI), is present to some degree in approximately 1.3% of adults in the U.S., even if it has not yet progressed to severe and visible symptoms.
“If left untreated, poor circulation can lead to pain in the legs when walking, gangrene and, in severe cases, major amputation,” said interventional cardiologist and endovascular specialist Jaafer Golzar, MD, Director of Endovascular Intervention at Advocate Christ and Advocate Aurora Research Institute’s principal investigator for that study site. “Fortunately, it can be treated with advanced surgical and endovascular procedures to re-establish blood flow.”
Vascular and interventional radiologist Mark Mewissen, MD, is Aurora St. Luke’s site principal investigator for study.
This study will compare the MOTIV® Sirolimus-Eluting Bioresorbable Vascular Scaffold to the current standard of care, which uses balloon angioplasty to treat blocked blood vessels below the knee.
In a balloon angioplasty, a small tube called a catheter is inserted into an incision and guided through the body’s chain of blood vessels to the site of the blockage, at which point a small balloon is inflated. The balloon flattens the obstructing plaque against the vessel wall, widening the opening and increasing blood flow. Doctors will then sometimes implant a mesh tube called a stent in the blood vessel to keep it open.
Occasionally even after a successful balloon angioplasty, blood vessels again become blocked, requiring a repeat procedure or leg amputation.
The MOTIV® Sirolimus-Eluting Bioresorbable Vascular Scaffold works similarly to a balloon angioplasty and stent by expanding the vessel to allow blood flow. Unlike a traditional stent, however, the MOTIV® scaffold has a unique property that allows for the stent to slowly dissolve over three to four years, leaving no permanent implant behind. It is also coated with a drug called sirolimus, which is frequently used in stents to prevent scar tissue formation, which can result in a blockage forming within the stent over time.
The MOTIV® scaffold is commercially available in Europe, whereas traditional balloon angioplasty is currently the only approved treatment for CLI in the U.S.
“This particular type of blockage is challenging to treat because of the small diameter of the blood vessel and the generally large amount of calcified plaque in the vessel, which is why finding additional treatment options is a priority for our researchers,” said Laura Wrona, MSN, director of the Research Institute’s Center of Excellence in Cardiovascular Research.
Researchers at sites throughout the world plan to enroll approximately 300 participants in the clinical trial, “MOTIV BTK randomized controlled trial,” which is sponsored by REVA Medical, Inc., manufacturer of the study device.
To learn more about our research, visit aah.org/research.