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School of Medicine
|Summary of Trial: ||The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD XP Emboli Capture Guidewire|
|Principal Investigator:||Mahmoud B Malas, M.D., MHS, FACS|
Umair Qazi, M.D., MPH
|Study Long Title:|
Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomye
|Study Short Title:||SAPPHIRE WW|
|JHU IRB Number:|
|Funding Source:||Cordis Inc.|
|Important Inclusion Criteria:|
High-surgical risk patients to be treated consistent with IFU labeling.
The subject or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee
|Important Exclusion Criteria:|
Subjects not treated per the IFU
Subjects who are contraindicated per the IFU
Inability or refusal to provide informed consent
|Clinical Trial Site:||Johns Hopkins Bayview Medical Center|
4940 Eastern Ave
Baltimore MD 21224
|Anticipated End Date:||2014|
|Compensation for Participating:||None|