CHOICE: Carotid Stenting For High Surgical-Risk Patients

Trial ID or NCT#

NCT00406055

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
  1. There are no exclusion criteria for this study

Investigator(s)

Ronald L. Dalman MD
Ronald L. Dalman MD
Vascular surgeon
Dr. Walter C. Chidester Professor

Contact us to find out if this trial is right for you.

CONTACT

Ronald Dalman
(650) 725-5227