EXACT study

The EXACT (Emboshield and Xact Post Approval Carotid Stent Trial) study is a post FDA approval single arm non-randomized study to evaluate the Xact carotid stent system when used by operators from various backgrounds and experiences. A total of 1500 subjects will be enrolled nationwide, no more than 50 from any single institution. As part of the study, patients will receive serial neurological evaluations performed by a study neurologist. These examinations will be pre-procedure, pre-discharge, 30 days post-operative and 1 year postoperative. Modified Rankin scores and National Institutes of Health stroke scale scores will be obtained at each visit.

The study population will consist of patients with carotid stenosis who are felt to be at increased risk for carotid endarterectomy due to anatomic factors or medical comorbidities. Symptomatic patients can be enrolled with 50% or greater carotid stenosis. Asymptomatic patients can be enrolled with 80% or greater stenosis. All cases will be confirmed angiographicaly by the primary investigator prior to carotid stenting. Qualifying medical comorbidities and anatomic factors include, but are not limited to, coronary artery disease, myocardial infarction, open heart surgery or cardiac bypass needed within 30 days, contralateral carotid occlusion, congestive heart failure, unstable angina, cardiac arrhythmia, respiratory insufficiency, renal failure, high carotid bifurcation, prior neck radiation, restenosis following carotid endarterectomy, tandem carotid lesions and pseudoaneurysm of the carotid artery.

Wingspan study

There are 468,000 cases of ischemic stroke yearly. Of these, about 20% are due to intracranial atheroscerotic disease (IAD). In the anterior circulation, IAD results in about a 5% yearly stroke rate on medical therapy (EC-IC study data). In the posterior circulation, IAD results in a 10%-20% yearly stroke rate on medical therapy (WASID study data). Angioplasty and stenting of IAD with coronary devices has been limited due to difficulty in navigating to intracranial sites with these stiff devices, stent related dissection and lack of durability for angioplasty alone.

The Wingspan stent and Gateway balloon is the first approved device in the United States for the treatment of intracranial atherosclerotic disease. The Wingspan stent and Gateway balloon catheter are available for distribution to a select number of centers across the nation that possess a large degree of experience with intracranial stenosis and intracranial stenting. The registry will collect outcomes and device performance data. The registry will consist of a multi-center, single arm observational study.

The Wingspan apparatus has been FDA approved under a humanitarian device exemption protocol. To qualify for use of this device patients must possess a symptomatic intracranial stenosis that has been refractory to medical therapy. Intracranial stenosis must be 50% or greater and can be either anterior or posterior circulation.