Trial to test device for vulnerable plaques
Trial to test device for vulnerable plaques
Rotterdam, the Netherlands - Tim Russert's sudden cardiac death following plaque rupture in his left anterior descending artery (LAD) rekindled a media firestorm over the difficulty of predicting and preventing vulnerable plaque rupture. A US company made a well-timed announcement earlier this week that physicians have implanted a device developed expressly to prevent plaque rupture into the LAD of a 64-year old man in Rotterdam—the first patient enrolled in its SECRITT I trial of the vProtect Luminal Shield .
The device looks much like a traditional stent, but according to its manufacturer, Prescient Medical, it has a number of features that its developers believe make it well-suited for use in softer, vulnerable plaques. Characterized as having "gentle deployment," the nitinol device is flexible and self-expanding, rather than balloon expandable, giving it a "mild chronic outward force" designed to reduce stent malapposition and vessel injury, while helping it conform more closely with the arterial wall. It has ultrathin (56-µm) struts and longitudinal "backbone" members that reduce "jumping" and foreshortening on deployment, a company spokesperson explained. Slight flaring at the ends of the shield device is intended to prevent migration of the device.
The SECRITT I trial is examining six-month outcomes in 15 patients with known vulnerable plaques (identified by ultrasound and optical imaging techniques) treated with the vProtect device and 15 control patients who also have vulnerable lesions, treated with optimal therapy. All 30 patients are elective, referred for cardiac catheterization for the treatment of a major lesion "impairing normal cardiac function," a press release states.
"We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture," lead investigator for the trial, Dr Patrick Serruys, (Erasmus University, Rotterdam, the Netherlands), states in the press release. "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."
Rotterdam, the Netherlands - Tim Russert's sudden cardiac death following plaque rupture in his left anterior descending artery (LAD) rekindled a media firestorm over the difficulty of predicting and preventing vulnerable plaque rupture. A US company made a well-timed announcement earlier this week that physicians have implanted a device developed expressly to prevent plaque rupture into the LAD of a 64-year old man in Rotterdam—the first patient enrolled in its SECRITT I trial of the vProtect Luminal Shield .
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vProtect Luminal Shield |
The device looks much like a traditional stent, but according to its manufacturer, Prescient Medical, it has a number of features that its developers believe make it well-suited for use in softer, vulnerable plaques. Characterized as having "gentle deployment," the nitinol device is flexible and self-expanding, rather than balloon expandable, giving it a "mild chronic outward force" designed to reduce stent malapposition and vessel injury, while helping it conform more closely with the arterial wall. It has ultrathin (56-µm) struts and longitudinal "backbone" members that reduce "jumping" and foreshortening on deployment, a company spokesperson explained. Slight flaring at the ends of the shield device is intended to prevent migration of the device.
The SECRITT I trial is examining six-month outcomes in 15 patients with known vulnerable plaques (identified by ultrasound and optical imaging techniques) treated with the vProtect device and 15 control patients who also have vulnerable lesions, treated with optimal therapy. All 30 patients are elective, referred for cardiac catheterization for the treatment of a major lesion "impairing normal cardiac function," a press release states.
"We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture," lead investigator for the trial, Dr Patrick Serruys, (Erasmus University, Rotterdam, the Netherlands), states in the press release. "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."
