CHOICE: Carotid Stenting For High Surgical-Risk Patients

Completed

Conditions studied: Carotid Artery Disease

In brief

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.

Key facts

Study ID

NCT00406055

Run by

Abbott Medical Devices

People needed

18855

Starts

2006-10-01

Expected to finish

2012-06-01

Last updated by the study team

2013-07-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient or patient's legally authorized representative provided informed consent.
• Patient is considered at high risk for carotid endarterectomy (CEA).
• Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
• Patients physician intends to use an RX Acculink with either the RX Accunet or Emboshield Nav 6 in the carotid artery OR the patients physician intends to use an Xact with the Emboshield or Emboshield Nav6 in the carotid artery as per the FDA approved Indications for Use as outlined.

You may not qualify if…

• There are no exclusion criteria for this study

Where it is running

• Abbott Vascular — Santa Clara, California, United States

Full record on ClinicalTrials.gov

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