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News

First-ever vulnerable plaque clinical trial sees patient receives vProtect Luminal Shield

Prescient Medical : 01 July, 2008  (Company News)
An interventional cardiology team led by Professor Patrick W Serruys has 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, The Netherlands.
The 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 USA, 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 stabilised the target lesions.

According to Professor Patrick W Serruys, MD, PhD, of Erasmus University, the SECRITT I trial represents the logical extension of modern cardiac medicine: 'We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture. 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.' Professor 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,' said professor Serruys.

The vProtect Luminal Shield is also undergoing clinical testing for indications where traditional stents are used - relatively stable, flow-limiting coronary lesions.

'The Shield was designed for use in soft lesions. The features that make it well suited for use in vulnerable plaque - including gentle, self-expanding deployment and ultra-thin struts - make it useful in other lesions where traditional balloon-expanding stents are currently used,' said Patricia Scheller, chief executive officer of Prescient Medical. 'There are some uses for which traditional stents do not perform optimally, such as in patients with acute coronary syndrome. These patients often have plaques that recently ruptured, and are prone to developing clots. The vProtect Luminal Shield was designed to match the mechanical properties of the coronary artery. It doesn't cause the same amount of injury as balloon-expandable stents, which should reduce some of the adverse effects associated with traditional stents,' she concluded.

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