Covidien has announced the start of enrolment in two clinical trials designed to further underscore the safety and effectiveness of the company’s advanced neurovascular solutions.
Baptist Medical Center in Jacksonville, Florida, USA, treated the first patient enrolled in the PREMIER Prospective study, an international Investigational Device Exemption (IDE) clinical study to evaluate the Pipeline embolisation device in smaller unruptured intracranial aneurysms. Separately, Baptist Health Lexington in Kentucky, USA, enrolled the first patient in the STRATIS Registry for endovascular stroke devices, which will evaluate the use of all Covidien market-released stroke devices.
The PREMIER study will enrol up to 141 patients in 20 global sites and is designed to assess the safety and effectiveness of the Pipeline device in the treatment of unruptured, small and medium wide-necked intracranial aneurysms.
“We are excited to be the first hospital to enrol 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,” says Ricardo Hanel, neurovascular surgeon with Lyerly Neurosurgery at Baptist Medical Center. “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 STRATIS Registry, a prospective, multicentre, non-randomised, observational registry designed to evaluate the use of Covidien endovascular stroke devices in patients diagnosed with an acute ischaemic stroke. Covidien’s current endovascular stroke device in the USA is the Solitaire 2 revascularisation device.
“The STRATIS Registry will assess mechanical thrombectomy as a treatment option in patients who cannot get access to or are not eligible for IV-tPA – a medication that dissolves blood clots,” says Curtis Given, co-director of neurointerventional services at Baptist Health Lexington. “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. In some states, insurance carriers are refusing to reimburse mechanical thrombectomy procedures, so it is 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.”
As many as 60 US sites are expected to participate in the STRATIS Registry, which will enrol up to 1,000 patients to collect clinical outcomes for interventional stroke patients in a real world setting.
