Prescient implants first luminal shield for plaque detection, begins clinical trial
An Amsterdam interventional cardiology team led by Patrick W. Serruys, MD, has successfully placed Prescient Medical’s vProtect luminal shield in the left anterior descending coronary artery of a 64-year-old man at Erasmus Medical Center in Rotterdam.
The case marks the start of a pilot study, SECRITT I, designed to evaluate the vProtect luminal shield as a treatment for vulnerable plaques, according to Prescient.
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, according to the Doylestown, Pa.-based company. The patients will be matched with 15 controls. Patients, who also have non-blood flow-limiting plaques or lesions that have been identified as vulnerable, will not receive the shield. All patients are elective patients that have been referred to the cath lab for the treatment of a major lesion impairing normal cardiac function, Prescient said.
The company also said that 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. The information will allow the investigators to observe whether the shield has stabilized the target lesions.
The case marks the start of a pilot study, SECRITT I, designed to evaluate the vProtect luminal shield as a treatment for vulnerable plaques, according to Prescient.
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, according to the Doylestown, Pa.-based company. The patients will be matched with 15 controls. Patients, who also have non-blood flow-limiting plaques or lesions that have been identified as vulnerable, will not receive the shield. All patients are elective patients that have been referred to the cath lab for the treatment of a major lesion impairing normal cardiac function, Prescient said.
The company also said that 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. The information will allow the investigators to observe whether the shield has stabilized the target lesions.