Covidien Begins Two Neurovascular Clinical Trials

September 15, 2014—Covidien plc announced the start of enrollment in two clinical trials designed to further demonstrate the safety and effectiveness of the company’s neurovascular solutions. 

The company advised that the PREMIER study is designed to assess the safety and effectiveness of the Pipeline device in the treatment of unruptured, small and medium wide-necked intracranial aneurysms. The study will enroll up to 141 patients at 20 global sites.

The STRATIS registry is a prospective, multicenter, nonrandomized, observational registry designed to evaluate the use of all Covidien endovascular stroke devices in patients diagnosed with an acute ischemic stroke. As many as 60 sites in the United States are expected to participate in the STRATIS registry, which will enroll up to 1,000 patients to collect clinical outcomes for interventional stroke patients in a real-world setting. The Solitaire 2 revascularization device is Covidien’s current endovascular stroke device in the United States.

The first patient enrolled in the study was treated at Baptist Medical Center in Jacksonville, Florida. Ricardo Hanel, MD, a neurovascular surgeon with Lyerly Neurosurgery at Baptist Medical Center, commented in Covidien’s announcement, “We are excited to be the first hospital to enroll a patient in this important study. There is a need for an effective and sustained treatment option for patients with wide-neck small or medium intracranial aneurysms. Redirecting blood flow away from the aneurysm with the Pipeline device has been shown to reduce aneurysm recurrence and the need for retreatment in large and giant internal carotid artery aneurysms. This study will provide valuable clinical evidence in a new population of aneurysms.”

The first patient enrolled in the STRATIS registry was treated at Baptist Health Lexington in Kentucky. Curtis Given, MD, who is Co-Director of Neurointerventional services at Baptist Health Lexington, stated, “The STRATIS registry will assess mechanical thrombectomy as a treatment option in patients who can’t get access to or are not eligible for intravenous tissue plasminogen activator (IV-tPA). It is very important to provide registry data to not only demonstrate the safety of a mechanical thrombectomy procedure on these patients, but also to track the outcomes, so we can compare the results to historical IV-tPA data.” Dr. Given added, “In some states, insurance carriers are refusing to reimburse mechanical thrombectomy procedures, so it’s vital that we collect the data to show not only safety, but efficacy, in order to ensure that we can continue to provide care to these patients that would otherwise not be offered any treatment for their stroke."