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SAPPHIRE WW

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
Study Coordinator:

Umair Qazi, M.D., MPH
Email: uqazi1@jhmi.edu

Study Long Title: 

Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomye

Study Short Title: SAPPHIRE WW
JHU IRB Number:

NA_00009974

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
Start Date:2009
Anticipated End Date:2014
Compensation for Participating: None











































 

 

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