Healthcare Industry News:  self-expanding 

Devices Interventional

 News Release - May 12, 2009

Enrollment Complete in the XCELL Trial - The First U.S. Study of Stent Placement to Study Arterial Blockages Below the Knee

Study to Evaluate Abbott’s Xpert(TM) self-expanding Stent System For Peripheral Arterial Disease

SPRINGFIELD, Ill.--(HSMN NewsFeed)--The XCELL trial, the first U.S. multicenter, prospective clinical trial to investigate the use of minimally invasive stent placement for severe peripheral arterial disease (PAD) below the knee, also referred to Critical Limb Ischemia (CLI), recently enrolled its 120th and final patient. The final patient was enrolled in the trial by Dr. Jeffrey Goldstein at St. John’s Hospital in Springfield, IL.

The study, sponsored by VIVA Physicians, Inc. (VPI) and supported by a research grant from Abbott, is the first in the U.S. to evaluate Abbott Vascular’s Xpert(TM) nitinol stent in the arterial vessels below the knee. VPI developed the protocol to study the stent’s usage in the tibial arteries below the knee, submitted the protocol application to the FDA for IDE approval, and contracted with a Trial Management Organization, Prairie Education and Research Cooperative (Springfield, IL), to assist with their data collection, evaluation, and reporting of the study results.

According to Dr. James Joye, D.O., the National Principal Investigator for the XCELL trial, "This trial is important because it is sponsored by a group of independent physicians who saw a need to evaluate a technology that might improve outcomes in patients with CLI, and who recognized that there are significant gaps in our medical knowledge of how to best treat such patients. Those with advanced disease may be poor candidates for surgery and have few treatment options, and many are at high risk of losing a limb,” Dr. Joye said. “The study’s primary endpoint is avoidance of major amputation at 12-months follow-up after treatment, and with enrollment being completed, we are one step closer to evaluating the outcomes for this patient population.”

The study was conducted at 16 centers in the United States. In addition to St. John’s Hospital (principal investigator- Nilesh Goswami, M.D.), other centers who participated in the study, and their principal investigators, included:

  • El Camino Hospital, Mountain View, CA; Jim Joye, D.O.
  • Community Hospital, Munster, IN; Satyaprakash. Makam, M.D.
  • St. Joseph Hospital, Orange, CA; Mahmood Razavi, M.D.
  • Midwest Cardiovascular Research Foundation, Davenport, IA; Eric Dippel, M.D.
  • Riverside Methodist Hospital, Columbus, OH; Charles Botti, M.D.
  • Presbyterian Hospital of Dallas, Dallas, TX; Tony Das, M.D.
  • North Central Heart Institute, Sioux Falls, SD; J. Michael Bacharach, M.D.

About self-expanding Stents

self-expanding stents are tiny cylinders made of metal mesh that are placed in blocked arteries during minimally invasive interventional procedures. In the technique, a catheter is inserted through a small nick in the skin and threaded through the blood vessels to the site of the blockage under X-ray guidance. The stent is deployed through the catheter and expanded to prop open the diseased artery.

About Peripheral Arterial Disease

PAD is a condition in which the arteries outside of the heart are narrowed or clogged by an accumulation of fat, cholesterol and other deposits that interfere with the normal flow of blood. As per the U.S. Bureau of Census, it is estimated that 25 million people suffer from blockages in the arteries of the lower leg. Symptoms of PAD in the legs may include pain while walking, numbness and tingling, cold feet or legs, and ulcers or sores that do not heal.

About VPI

VPI is a multi-disciplinary group of independent physicians who are nationally known experts in the diagnosis and management of all peripheral vascular diseases, and who are joined together to advance education in vascular medicine and support research and innovative treatment options. In 2002, the group of 10 specialists in vascular medicine, vascular surgery, interventional cardiology and interventional radiology, organized VIVA: The National Education Course for Endovascular Interventions, an annual educational symposium held in Las Vegas that provides a highly interactive educational forum. The XCELL study is one of three clinical trials sponsored by VPI and meets the group's goal of sponsoring and executing trials that will support standards of practice. VPI is also involved in developing objective performance criteria for limb salvage, lower extremity peripheral arterial disease interventions, and renal vascular disease interventions.

Source: VIVA Physicians, Inc.

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