Date: 6/13/2007

Community Hospital is one of only 10 sites in U.S. to enroll patients in clinical trial to evaluate restoring blood flow to the lower legs

MUNSTER — Community Hospital is the first in the Northwest Indiana and one of only 10 sites across the United States to begin enrolling patients in the XCELL clinical trial to evaluate the use of an investigational self-expanding stent to restore blood flow in the lower legs of patients who have insufficient blood circulation, and who may be at risk for amputation.

“This trial is at the forefront of studying technology that may save limbs,” Principal Investigator Prakash Makam, M.D., said. “This is a prestigious study, and since this research is being conducted at Community Hospital, the benefits are great for people who live in Northwest Indiana and the Chicagoland area.”

Peripheral arterial disease, or obstruction of blood flow in the extremities or limbs, and most often in the lower legs, is also called critical limb ischemia (CLI). The spectrum of clinical symptoms in CLI patients range from reproducible leg discomfort when patients are walking or ambulating, to severe pain when patients are at rest, to skin ulceration and gangrene that can lead to amputation when circulation is not restored.

According to recent literature, more than 10 percent of the general population and up to 20 percent of people over the age of 70 have some degree of peripheral artery disease. In the United States, peripheral artery disease affects roughly 25 million Americans annually.

“The whole reason behind this trial is to find more ways to restore blood flow as this may prevent amputation of limbs of patients who have CLI,” Makam said. “There are a limited number of options for people with CLI. This trial will help us acquire new knowledge of effective treatment options.”

The XCELL clinical trial is designed to address the needs of individuals suffering from advanced stages of blockages below the knee. Designed by VPI, VIVA Physicians Inc., the XCELL trial has been approved by the U.S. Food and Drug Administration (FDA) to use a proprietary system designed by Abbott, called the Xpertâ„¢ Self-Expanding Stent System, to treat patients with CLI who have limited treatment options and who are at a very high risk of losing a lower limb. The FDA will carefully observe patient outcomes during the entire course of the XCELL study to determine the appropriate patient population to treat in future studies of medical intervention below the knee.

For more information about XCELL, visit: To inquire about enrolling as a patient in the XCELL study, call Cardiology Associates of Northwest Indiana at 219-934-4200.

“Patients with critical limb ischemia are frequently unaware of their treatment options, and the outcomes of data in this area of treatment are limited,” said Jim Joye, DO of VIVA Physicians Inc. and National Principal Investigator for the study. “XCELL is a landmark trial designed to expand patient treatment options, increase physician awareness about critical limb ischemia, and to take an important step forward towards eventually preventing amputation.”

VPI, VIVA Physicians Inc., is a group of physicians that have come together to address vital medical questions about peripheral vascular disease treatment in a balanced and collaborative environment. The group consists of national clinical and research experts representing a broad array of specialties. The group is dedicated to developing and disseminating research results and best practices about peripheral vascular disease treatment through scientific publications, presentations and teaching courses. The XCELL study meets the group’s goal of sponsoring and executing trials designed to support and improve standards of practice for peripheral vascular disease treatment. VPI is also developing objective performance criteria for limb salvage and for interventions to treat lower extremity peripheral arterial disease, and it is investigating strategies to address in-stent restenosis and acute stroke.