Trial Search Results

CHOICE: Carotid Stenting For High Surgical-Risk Patients

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Abbott Medical Devices

Stanford Investigator(s):

Intervention(s):

  • Device: RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6

Eligibility


Inclusion Criteria:

   1. Patient or patient's legally authorized representative provided informed consent.

   2. Patient is considered at high risk for carotid endarterectomy (CEA).

   3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery
   disease.

   4. 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.

Exclusion Criteria:

There are no exclusion criteria for this study

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ronald Dalman
6507255227
Not Recruiting