Pharma major Abbott has announced the launch of clinical trials to study the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in patients with iliac artery disease.
The new Absolute Pro peripheral stent is a self-expanding nitinol stent with a flexible and conformable design that is intended to keep lesions open without introducing more metal than necessary to treat a narrowing. The peripheral stent delivery system is compatible with 0.035" (0.89 mm) guide wires.
It is currently an investigational device in the United States for the treatment of iliac artery disease.
Iliac artery disease is a form of peripheral artery disease (PAD) that affects the lower extremities. The first patient was enrolled into the MOBILITY trial by John Campbell, assistant professor of surgery and medicine, West Virginia University School of Medicine.
"Iliac artery occlusive disease has the potential not only to have a significant impact on a patient's ability to carry on daily activities, but it also can be an early sign of plaque buildup in other parts of the body," said Manish Mehta, director of Endovascular Services, The Vascular Institute for Health and Disease, Albany Medical Center in Albany, N.Y., and co-principal investigator of the MOBILITY trial. "The lower extremity discomfort and fatigue with walking and exercise caused by this debilitating disease can tremendously impact a patient's overall quality of life, making it critical to find effective treatments. Data from the MOBILITY trial will be an important addition to iliac stenting research."
PAD affects approximately 8 million people in the United States, and occurs when the blood vessels in the legs become blocked or narrowed by plaque, reducing blood flow to the limbs. The most common symptom of PAD is claudication, a sharp, cramp-like pain in the legs that occurs when walking or exercising. For patients with iliac artery disease, claudication occurs most frequently in the thigh or hips. PAD most commonly affects people age 40 and older, and can lead to reduced walking capacity, chronic pain and immobility, disability, and potentially amputation. PAD can be treated with medications, exercise, angioplasty, stenting or surgery.
"As medical technology has advanced, iliac stenting has become an excellent first-line interventional treatment option for patients, as it is less invasive than surgery and has the potential to improve patient outcomes," said Tony S. Das, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY trial. "The MOBILITY trial will provide understanding into how the Absolute Pro peripheral stent treats the narrowing in the iliac artery to improve blood flow to the leg, with the ultimate goal of alleviating pain associated with PAD and improving the patient's ability to walk and exercise."
The MOBILITY trial is designed to study 150 patients at up to 50 centers in the United States. The primary endpoint is a composite measure of major adverse events (MAE) at nine months. MAE is defined as death due to any cause, heart attack (myocardial infarction), clinically driven target lesion revascularization and limb loss (amputation only) on the treated side(s).
"With iliac interventions, safety and efficacy are critical when considering treatment options. The MOBILITY trial will provide valuable evidence about the performance of the Absolute Pro peripheral stent, and it will be used as the basis for a peripheral vascular indication filing for the device," said Charles Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.