SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

IRB Number

06-111

ClinicalTrials.gov Identifier

NCT00403078

Trial Status

Open for Enrollment
Phase Post Market

Why is this study being done?

Carotid stent supported angioplasty is an approved procedure being offered as an alternative to carotid artery surgery for narrowed carotid arteries (the blood vessels that carry blood to the brain). This study will allow Cordis to collect information about the stent and distal protection and the patients who are treated with it.

Who is eligible to participate?

High risk surgical patients with a qualifying narrowing of the carotid arteries are eligible.

What is involved?

Patients will undergo a physical examination, ultrasound of the neck, blood tests, and be asked to complete a questionnaire. Patients will then undergo angioplasty and stenting of their carotid arteries. After hospital discharge, patients will be asked to return to the clinic for one follow-up visit.

How long is the study?

Patients will be in the study for approximately 30 days.

Who can I contact for additional information?

Please contact Tiffany Whitaker, R.N.,MA,CCRP at (217) 545-2531 or email:twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Kim Hodgson, MD

Where is the trial located?

Springfield, Illinois