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|Summary of Trial: ||The purposes of this study is to 1) Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. 2) Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.|
|Principal Investigator:||Mahmoud B Malas, M.D., MHS, FACS|
Umair Qazi, M.D., MPH
|Study Long Title:|
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
|Study Short Title:||CHOICE|
|JHU IRB Number:|
|Funding Source:||Abbott Vascular Inc.|
|Important Inclusion Criteria:|
Patient is considered at high risk for carotid endarterectomy (CEA).
Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
Patient’s physician intends to use an RX Acculink with the RX Accunet in the carotid artery or an Xact with the Emboshield in the carotid artery as per the FDA approved Indications for Use as outlined below:
Patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram.
|Clinical Trial Site:||Johns Hopkins Bayview Medical Center|
4940 Eastern Ave
Baltimore MD 21224
|Anticipated End Date:||2014|
|Compensation for Participating:||None|