FDA Approves First U.S. Study Of Stent Placement To Treat Arterial Blockages Below The Knee
The study, sponsored by VIVA Physicians, Inc. (VPI) and supported by a restricted educational grant from Abbott Laboratories, will be the first in the U.S. to evaluate the Xpert(TM) expandable nitinol stent in the blood vessels below the knee. The Xpert, which is manufactured by Abbott Vascular Inc., is cleared in the U.S. to treat blockages in the biliary ducts that carry digestive enzymes from the liver. VPI submitted its IDE application to study the stent's use in the popliteal and tibial arteries below the knee to the FDA on Feb. 7.
"The Xpert stent is particularly appropriate for this trial because it is the only self-expanding stent that comes in a variety of sizes small enough to treat the blood vessels below the knee," said James Joye, D.O., principal investigator for the XCELL trial. Dr. Joye's center, El Camino Hospital in Mountain View, Calif. will be among the sites participating in the study. "The study is also important because it is one of only a very few independent, physician-sponsored efforts. VPI set the protocol, applied for the IDE and is responsible for data collection, evaluation and reporting.
"The primary endpoint of the study is avoidance of major amputation at 12-months follow-up after treatment," he said.
It is estimated that 25 million people suffer from blockages in the arteries of the lower leg. "Those with advanced disease may be poor candidates for surgery and have few treatment options. Many are at high risk of losing a limb," Dr. Joye said. "This is an important trial to expand patient treatment options, increase physician awareness and take an important step forward in preventing amputation."
The study is expected to enroll 140 patients at 10 centers, according to Dr. Joye. In addition to El Camino Hospital, other centers participating in the study, and their principal investigators include:
-- UCLA Medical Center, Los Angeles; Thomas McNamara, M.D.
-- St. John's Hospital/Memorial Medical Center, Springfield, Ill.; Nilesh Goswami, M.D.
-- Midwest Cardiovascular Research Foundation, Davenport, Iowa; Eric Dippel, M.D.
-- Ochsner Clinic Foundation, New Orleans; Christopher White, M.D.
-- Washington University, St. Louis, Mo.; Patrick Geraghty, M.D.
-- Riverside Methodist Hospital, Columbus, Ohio; Charles Botti, M.D.
-- CAMC Memorial, Charleston, W. Va.; Mark Bates, M.D.
-- University of Virginia, Charlottesville, Va.; John Angle, M.D.
-- Presbyterian Hospital of Dallas; Tony Das, M.D.
About the Stent
The Xpert self-expanding stent is a tiny cylinder made of metal mesh that is placed in the artery during a minimally invasive interventional procedure. 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. 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 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, "turf neutral" educational forum. The XCELL study is VPI's first clinical trial and meets the group's goal of sponsoring and executing trials that will support standards of practice. VPI also is involved in developing objective performance criteria for limb salvage and interventions for lower extremity peripheral arterial disease, and is investigating strategies to deal with in-stent restenosis and acute stroke intervention.
Abbott Vascular Inc. is a division of Abbott Laboratories headquartered in Redwood City, Calif.
VIVA Physicians, Inc
http://www.vivapvd.com/precourses.cfm
În primul rând SUA FDA aprobã Studiul stent de plasare pentru a trata arteriale înfundãrii Mai jos genunchiul - FDA Approves First U.S. Study Of Stent Placement To Treat Arterial Blockages Below The Knee - articole medicale engleza - startsanatate