Patient Receives vProtect Luminal Shield in First-Ever Vulnerable Plaque Clinical Trial
July 1, 2008 - An interventional cardiology team this week led by Professor Patrick W. Serruys, M.D., Ph.D, successfully placed a vProtect Luminal Shield in the left anterior descending (LAD) coronary artery of a 64-year-old man at Erasmus Medical Center in Rotterdam.
This case marks the start of a pilot study, known as SECRITT I, designed to evaluate the vProtect Luminal Shield as a treatment for vulnerable plaques - atherosclerotic deposits in the coronary arteries that do not produce symptoms until they rupture with potentially fatal consequences. There are more than 500,000 sudden cardiac deaths in the U.S., and more than 300,000 in Europe, every year. The sudden and unexpected passing of Tim Russert, host of NBC’s Meet the Press, is thought to have been the result of a vulnerable plaque rupture.
The SECRITT investigators plan to place the self-expanding vProtect Luminal Shield in 15 patients with plaques identified as vulnerable by a combination of ultrasound and optical imaging techniques. These patients will be matched with 15 controls-patients who also have non-blood-flow-limiting plaques or “lesions” that have been identified as vulnerable-who will not receive the shield. All patients are elective patients that have been referred to the cathlab for the treatment of a major lesion impairing normal cardiac function. All 30 patients will undergo follow-up diagnostic catheterizations six months after the initial treatment visit, at which time their lesions will be re-evaluated. This information will enable the investigators to observe whether the shield has stabilized the target lesions.
“We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture,” Dr. Serruys said. “The kind of plaques we are treating in SECRITT do not cause symptoms or seriously affect blood flow, but they are prone to rupture, which can cause a clot, or thrombus. The vProtect Luminal Shield is designed to prevent that rupture, thereby preventing the thrombus, and the resulting heart attacks.”
Dr. Serruys has been the director of the Clinical Research Program of the Catheterization Laboratory at the Thoraxcenter, Erasmus University since 1980 and the head of the interventional cardiology department since 1997. He is a fellow of the American College of Cardiology and the European Society of Cardiology and a member of the Scientific Council of the International College of Angiology.
Recent studies have shown that most “culprit” lesions in heart attacks, or myocardial infarctions (MI) narrow the vessel lumen by less than 50 percent prior to the infarct, and only 15 percent of acute, or sudden, MIs arise from lesions that are more than 60 percent narrowed on a previous angiogram. Most of these vulnerable plaques would not be eligible for treatment with angioplasty and stenting.
“Now is the time to take a new approach, to try and prevent the plaque rupture and prevent the acute event, rather than try to repair the damage after the fact,” Dr. Serruys said.
The vProtect Luminal Shield was designed to match the mechanical properties of the coronary artery and the maker said it does not cause the same amount of injury as balloon-expandable stents.
For more information: www.prescientmedical.com
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